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GMC Medical

Laboratoires Dermo Cosmetik Inc

GMC Medical Acne Treatment


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACNE-CLEAR CLEANSING GEL (7 fl. oz.)

Drug Facts

Active ingredients

Salicylic Acid 2.0%

Purpose

Acne Treatment

GMC Medical Uses

  • Clears acne blemishes.

WARNINGS

For external use only

When using this product:

  • Do not use near or in the eyes.
  • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.
    If irritation occurs, only use one topical acne medication at a time.

Stop use and ask a doctor if:

  • Sensitivity develops or increases
  • Irritation becomes severe

Keep out of reach of children.

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

DIRECTIONS

  • Apply and emulsify carefully with wet fingers and rinse thoroughly twice a day, or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce frequency of application.
  • 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, SODIUM LAURYL GLUCOSE CARBOXYLATE, LAURYL GLUCOSIDE, COCOBETAINE, COCO-GLUCOSIDE, GLYCERYL OLEATE, SODIUM CITRATE, GLYCERIN, PANTHENOL, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ARCTIUM MAJUS ROOT (BURDOCK) EXTRACT, ARNICA MONTANA FLOWER EXTRACT, URTICA DIOICA (NETTLE) EXTRACT, EQUISETIUM ARVENSE (HORSETAIL) EXTRACT, BETULA ALBA LEAF EXTRACT, SALVIA OFFICINALIS (SAGE) LEAF EXTRACT, PEUMUS BOLDUS LEAF EXTRACT, BUTYLENE GLYCOL, XANTHAN GUM, ALLANTOIN, PEG-120 METHYL GLUCOSE DIOLEATE

OTHER INFORMATION

Store at 59-86°F (15-30°C).

QUESTIONS?

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

ACNE BPO GEL-CREAM (Net wt. 1.8 oz.)

Drug Facts

Active ingredients

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 Sun Protection Cream).
  • 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 Sun Protection Cream). 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 - Kit Carton

GMC MEDICAL®

ACNE TREATMENT
BENZOYL PEROXIDE &
SALICYLIC ACID

NDC 64127-135-01
NPN 80047121

NDC 64127-145-01

NDC 64127-155-01

GMC Medical

GMC Medical

salicylic acid and benzoyl peroxide KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64127-155
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64127-155-01 1 in 1 BOX

Marketing Information

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


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