AMBI ACNE SPOT TREATMENT- benzoyl peroxide cream 
Valeant Pharmaceuticals North America LLC

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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AMBI Even & Clear® Acne Spot Treatment

Drug Facts

Active Ingredient

Benzoyl Peroxide 5%

Purpose

Acne Treatment

Use

For the treatment of acne.

Warnings

For external use only

Do not use if you are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation. If excess irritation occurs, discontinue use.

Ask a doctor or pharmacist before use if you are using any topical acne drugs at the same time or right after use of this product. This may cause irritation, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. If irritation becomes severe, discontinue use. If irritation still continues, consult a doctor.

When using this product

Avoid contact with eyes. If contact occurs, flush thoroughly with water.
Keep away from lips and mouth
Avoid unnecessary sun exposure and use a sunscreen
Avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.

Stop use and ask a doctor if excess irritation occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wash skin thoroughly and dry.
Apply directly on blemishes.
Apply one a day intially, then 2 to 3 times daily. If dryness or mild peeling occurs, reduce application to once a day, as needed.

Inactive ingredients

Water, Glycerin, Methylpropanediol, Acryaltes/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Sodium Hydroxide, Sodium Benzoate, Bisabolol, Ethylhexylglycerin, Tetrasodium EDTA, Butylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Sea Whip Extract, Zingiber Officinale (Ginger) Root Extract, Benzalkonium Chloride, Leuconostoc/Radish Root Ferment Filtrate, Alcohol, Methylparaben, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben

Questions or Comments?

1-800-321-4576 M-F 8 a.m.-5 p.m.

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

AMBI® SKINCARE

EVEN & CLEAR®
Acne Spot
Treatment

Advanced 5%
Micro-Benzoyl Peroxide

Fast & Gentle
Advanced Formula

NET WT. 1 OZ. (28 g)

Principal Display Panel
AMBI ACNE SPOT TREATMENT 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-5485
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide1.4 g  in 28 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
LEVOMENOL (UNII: 24WE03BX2T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE SODIUM (UNII: MP1J8420LU)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CHAMOMILE (UNII: FGL3685T2X)  
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
GINGER (UNII: C5529G5JPQ)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
ALCOHOL (UNII: 3K9958V90M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-5485-011 in 1 CARTON01/17/2014
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/17/201402/21/2017
Labeler - Valeant Pharmaceuticals North America LLC (042230623)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135MANUFACTURE(0187-5485)

Revised: 2/2017
 
Valeant Pharmaceuticals North America LLC