MetroGel

Name: MetroGel

Inform MD

Before taking metronidazole, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to metronidazole or to any of its ingredients
  • have or have had Crohn’s disease
  • have or have had liver problems
  • have or have had kidney problems
  • have or have had blood disorders
  • have or are being treated for alcohol dependence
  • are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

MetroGel Overdose

If you take too much metronidazole, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If metronidazole is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

MetroGel FDA Warning

Metronidazole has been shown to be carcinogenic in mice and rats. Unnecessary use of the drug should be avoided.

MetroGel Dosage and Administration

Apply and rub in a thin film of MetroGel once daily to affected area(s).

A gentle cleanser should be used before the application of MetroGel.

Cosmetics may be applied after the application of MetroGel.

Not for oral, ophthalmic or intravaginal use.

Patient Counseling Information


Patients using MetroGel should receive the following information and instructions:
  1. This medication is to be used as directed.
  2. It is for external use only.
  3. Avoid contact with the eyes.
  4. Cleanse affected area(s) before applying MetroGel.
  5. This medication should not be used for any other condition than that for which it is prescribed.
  6. Keep out of reach of children.
  7. Patients should report any adverse reaction to their physicians.

RX Only

US Patent No. 6,881,726 and 7,348,317


Manufactured by:
G Production Inc.
Baie d'Urfé, Quebec, H9X 3S4 Canada
Made in Canada

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA

Part Number





metrogel 1%

(metronidazole gel), 1%

NDC 0299-3820-60

Rx Only

NET WT. 60 g

GALDERMA

For topical use only. Not for oral, ophthalmic or intravaginal use.

Store at controlled room temperature, 20° - 25°C (68° to 77°F), excursions permitted between 15° - 30°C (59° and 86°F). Keep out of reach of children.

Ususal dosage: Apply a thin film to the entire affected areas after washing once daily in the evening or as directed by the physician. Avoid applicaton close to the eyes.

Each gram contains: 10 mg (1%) metronidazole as active ingredient in a gel base consisting of betadex, edetate disodium, hydroxeyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben, and purified water.

US Patent No. 6,881,726 and 7,348,317

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA

Manufactured by:
G Production Inc.
Baie d'Urfé Quebec H9X 3S4 Canada
Made in Canada.
www.MetroGel.com

P50741-3


LOT:

EXP.:





Rx Only     NDC 0299-3820-01

metrogel 1%

(metronidazole gel), 1%

PUMP


For topical use only       NET WT. 55 g

GALDERMA

For topical use only. Not for oral, ophthalmic or intravaginal use.

Store at controlled room temperature, 20° - 25°C (68° to 77°F), excursions permitted between 15° - 30°C (59° and 86°F). Keep out of reach of children.

Ususal dosage: Apply a thin film to the entire affected areas after washing once daily in the evening or as directed by the physician. Avoid applicaton close to the eyes.

Each gram contains: 10 mg (1%) metronidazole as active ingredient in a gel base consisting of betadex, edetate disodium, hydroxeyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben, and purified water.

US Patent No. 6,881,726 and 7,348,317

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA

Manufactured by:
G Production Inc.
Baie d'Urfé Quebec H9X 3S4 Canada
Made in Canada.
GALDERMA is a registered trademark.

P51727-1


LOT:

EXP.:

MetroGel 
metronidazole gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0299-3820
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METRONIDAZOLE (Metronidazole) Metronidazole 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
betadex  
edetate disodium  
methylparaben  
niacinamide  
phenoxyethanol  
propylene glycol  
propylparaben  
water  
Packaging
# Item Code Package Description
1 NDC:0299-3820-60 60 g in 1 TUBE
2 NDC:0299-3820-01 55 g in 1 BOTTLE, PUMP
3 NDC:0299-3820-03 3 g in 1 TUBE
4 NDC:0299-3820-00 3 g in 1 BLISTER PACK
5 NDC:0299-3820-99 55 g in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021789 06/30/2005
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
Name Address ID/FEI Operations
G Production Inc. 251676961 manufacture(0299-3820)
Revised: 06/2012   Galderma Laboratories, L.P.

For the Consumer

Applies to metronidazole topical: topical cream, topical emulsion, topical gel/jelly, topical lotion

Other dosage forms:

  • vaginal cream, vaginal gel/jelly, vaginal suppository

Along with its needed effects, metronidazole topical (the active ingredient contained in MetroGel) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects of metronidazole topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Dry skin
  • redness or other signs of skin irritation not present before use of this medicine
  • stinging or burning of the skin
  • watering of eyes
Rare
  • Metallic taste in the mouth
  • nausea
  • tingling or numbness of arms, legs, hands, or feet

For Healthcare Professionals

Applies to metronidazole topical: topical cream, topical gel, topical kit, topical lotion, vaginal gel with applicator

General

Topical: The most frequently reported side effects were nasopharyngitis, upper respiratory tract infection, and headache.

Vaginal: The most frequently reported side effects were fungal infection, vulvovaginal candidiasis, headache, vulvovaginal pruritus, nausea, diarrhea, metrorrhagia, breast pain, infection, rash, pharyngitis, abdominal pain, pruritus, and dysmenorrhea.[Ref]

Local

Very common (10% or more): Mild dryness (17.1%), mild scaling (16.2%)
Common (1% to 10%): Moderate dryness, moderate scaling, mild pruritus, moderate pruritus, severe pruritus, mild stinging/burning, moderate stinging/burning, severe stinging/burning, local allergic reaction
Uncommon (0.1% to 1%): Severe dryness, severe scaling
Frequency not reported: Application site reaction, condition aggravated, transient redness[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea, breast pain, metrorrhagia, vulvovaginal candidiasis, vulvovaginal pruritus, urinary tract infection, vaginal itching/irritation/burning/numbness, pelvic discomfort, vaginal discharge
Uncommon (0.1% to 1%): Vaginal mycosis, urine discolored, vulva edema, menstrual discomfort/irregularities, vaginal spotting/bleeding
Frequency not reported: Breast enlargement, dysuria, female lactation, labial edema, leucorrhoea, menorrhagia, salpingitis, urinary frequency, vaginitis, vulvovaginal disorder[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, nausea, diarrhea, gastritis, tooth disorder, gastrointestinal discomfort, abdominal cramps, vomiting
Uncommon (0.1% to 1%): Constipation, dry mouth, abdominal bloating/noise
Frequency not reported: Dyspepsia, flatulence, gingivitis[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Tingling/numb extremities, taste metallic, dysgeusia, paresthesia, hypothesia
Frequency not reported: Peripheral neuropathy, ataxia
Postmarketing reports: Taste perversion[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, bronchitis, nasopharyngitis, sinusitis, upper respiratory tract infection, nasal congestion
Frequency not reported: Asthma, rhinitis[Ref]

Cardiovascular

Common (1% to 10%): Hypertension[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash, contact dermatitis, dry skin, skin discomfort, burning/stinging, erythema, worsening of rosacea, skin irritation
Frequency not reported: Acne, sweating, urticaria, skin exfoliation, facial edema, zoster lesion, nose pustule, vesicular bullous eruption
Postmarketing reports: Hyperpigmentation, pigmentation disorder, hypertrichosis[Ref]

Other

Very common (10% or more): Fungal infection (12%), flu syndrome (up to 11%)
Common (1% to 10%): Infection, influenza, abscess, pain
Uncommon (0.1% to 1%): Fatigue
Frequency not reported: Mucous membrane disorder[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depression, difficult sleep, irritability
Frequency not reported: Insomnia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain, cramp[Ref]

Oncologic

Uncommon (0.1% to 1%): Basal cell carcinoma
Frequency not reported: Skin cancer[Ref]

Ocular

Frequency not reported: Eye irritation, watery eye
Postmarketing reports: Eyelid edema[Ref]

Hepatic

Frequency not reported: Liver function test abnormal[Ref]

Immunologic

Frequency not reported: Allergic reaction[Ref]

Metabolic

Common (1% to 10%): Appetite decreased
Frequency not reported: Anorexia, hypomagnesemia[Ref]

Renal

Frequency not reported: Pyelonephritis[Ref]

Some side effects of MetroGel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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