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GMC Medical

Laboratoires Dermo Cosmetik Inc

GMC Medical Acne-BPO


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Benzoyl Peroxide 5.0%

Purpose

Acne Treatment Cream

GMC Medical Uses

  • Treats acne
  • Dries up acne pimples
  • Helps prevent new acne pimples

Warnings

For external use only

Do not use if you:

  • Have very sensitive skin.
  • Are sensitive to benzoyl peroxide.

When using this product:

  • Avoid unnecessary sun exposure and use sunscreen (GMC MEDICAL SPF50+).
  • Avoid contact with the eyes, lips and mouth.
  • Avoid contact with hair and dyed fabrics, which may be bleached by this product.
  • Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. Only one drug should be used unless directed by a doctor.
  • Skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently.

Stop use and ask a doctor if:

  • Irritation becomes severe
  • Sensitivity develops or increases
  • No substantial improvement occurs within 3 to 4 weeks or for more severe cases

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wash hands with a non-medicinal soap (without benzoyl peroxide)
  • Clean the skin thoroughly (GMC MEDICAL Acne-Clear Cleansing Gel) before applying
  • Cover the entire affected area with a thin layer 1 to 2 times daily or as directed by a doctor
  • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 times daily if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • If going outside, use sunscreen (GMC MEDICAL SPF50+). Allow benzoyl peroxide to dry, then follow directions in the sunscreen labelling. If irritation or sensitivity develops, stop use of both products and ask a doctor
  • Sensitivity Test for a New User. Apply product sparingly to 1 or 2 small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above

Inactive ingredients

WATER/EAU, BUTYLENE GLYCOL, ORYZA SATIVA (RICE) BRAN EXTRACT, BOSWELLIA SERRATA EXTRACT, HONEY EXTRACT/EXTRAIT DE MIEL, OLIGOPEPTIDE-10, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, ALGAE EXTRACT (MACROCYSTIS PYRIFERA, LAMINARIA, FUCUS VESICULOSUS, PHAEOPHYCEAE, RHODOPHYCEAE), GLYCERIN, DIMETHICONE, NIACINAMIDE, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, POLYSORBATE 80, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SILICA, MADECASSOSIDE, ALLANTOIN, PANTHENOL, C12-15 ALKYL BENZOATE, SODIUM HYALURONATE, CARBOMER, TEA TREE LEAF (MELALEUCA ALTERNIFOLIA) OIL, TRICAPRYLIN, POLYMETHYL METHACRYLATE, CITRUS PARADISI (GRAPEFRUIT) PEEL OIL, PHENOXYETHANOL, DISODIUM EDTA, SODIUM HYDROXIDE, ETHYLHEXYLGLYCERIN

Questions?

USA: 1 (800) 341-1531
CANADA: 1 (800) 361-1263

PRINCIPAL DISPLAY PANEL - 50 ml Tube Box

GMC MEDICAL®

ACNE BPO
GEL-CREAM

5%
Benzoyl Peroxide

Acne Treatment
Oily to Acne-Prone Skin
Paraben-Free ▪ Fragrance-Free

NDC 64127-145-01

50 ml - Net wt. 1.8 oz.

GMC Medical

GMC Medical

benzoyl peroxide GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64127-145
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 51.9 mg

Inactive Ingredients

Ingredient Name Strength
water
1,3-BUTYLENE GLYCOL
RICE BRAN
INDIAN FRANKINCENSE
HONEY
Aloe Vera Leaf
GLYCERIN
DIMETHICONE
NIACINAMIDE
Isohexadecane
polysorbate 80
SILICON DIOXIDE
MADECASSOSIDE
ALLANTOIN
PANTHENOL
ALKYL (C12-15) BENZOATE
HYALURONATE SODIUM
TEA TREE OIL
TRICAPRYLIN
GRAPEFRUIT OIL
PHENOXYETHANOL
EDETATE DISODIUM
SODIUM HYDROXIDE
ETHYLHEXYLGLYCERIN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 TUBE
2 NDC:64127-145-02 3 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2014-02-10


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