GMC Medical® Acne-BPO

Drug Labeling and Warnings

Drug Details [pdf]

GMC MEDICAL  ACNE-BPO- benzoyl peroxide gel 
Laboratoires dermo Cosmetik Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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GMC Medical®
Acne-BPO

Drug Facts

Active ingredient

Benzoyl Peroxide 5.0%

Purpose

Acne Treatment Cream

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.

Principal Display Panel - 50 ml Tube Box
GMC MEDICAL   ACNE-BPO
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64127-145
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzoyl peroxide (UNII: W9WZN9A0GM) (benzoyl peroxide - UNII:W9WZN9A0GM) benzoyl peroxide51.9 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
RICE BRAN (UNII: R60QEP13IC)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
HONEY (UNII: Y9H1V576FH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MADECASSOSIDE (UNII: CQ2F5O6YIY)  
ALLANTOIN (UNII: 344S277G0Z)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TEA TREE OIL (UNII: VIF565UC2G)  
GLYCERYL TRICAPRYLATE (UNII: 6P92858988)  
GRAPEFRUIT OIL (UNII: YR377U58W9)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64127-145-011 in 1 BOX02/10/201409/04/2015
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC: 64127-145-023 mL in 1 TUBE; Type 0: Not a Combination Product02/10/201409/04/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D02/10/201409/04/2015
Labeler - Laboratoires dermo Cosmetik Inc (249335480)

Revised: 1/2019
Document Id: b8e5bf77-248f-4265-8c96-242a0b415a9a
Set id: 21f8c814-2eb8-4028-9b5f-57a52c1e0859
Version: 2
Effective Time: 20190109
 
Laboratoires dermo Cosmetik Inc