CLEANSER ACNE CLEARING TREATMENT- benzoyl peroxide liquid 
CarePluss Pharma S.A. de C.V.

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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Active Ingredients:                      Purpose:
Sulphur 5%...........................................Acne medication

Uses:For the management of acne

Warnings: For external use only. When using this product skin irritation and dryness may occur.

Do not use

When using this product
Stop use and ask a doctor if

Keep out of reach of children.If swallowed get medical help or contact a Poison Control center immediately.

Directions:

Ingredients: Purified Water, Sulfer, Catalase, Aqueous extract of arnica, Glycerin, Cetyl Alcohol, Ceteareth-12, Bromelain, Ultrez 21, Mineral Oil, Ethhylene Glycol, Propylene Glycol, Sodium Ascorbyl Phosphate, Triethanolamine, Ascorbic Acid, Dodecyl Benzene Sulfonate, Peppermint oil, Piperine, Mint Base, EDTA, BHT, BHA, Methylparaben, Propylparaben.

2 FL OZ / 60 ml

label
Treatment 101
Acne Clearing Treatment
CLEANSER  ACNE CLEARING TREATMENT
benzoyl peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51439-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE.006 mg  in .024 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9)  
ETHYLENE GLYCOL (UNII: FC72KVT52F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
TROLAMINE (UNII: 9O3K93S3TK)  
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
VITAMIN A (UNII: 81G40H8B0T)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
POMEGRANATE (UNII: 56687D1Z4D)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
EDETIC ACID (UNII: 9G34HU7RV0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51439-005-01.024 mg in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/06/2012
Labeler - CarePluss Pharma S.A. de C.V. (815061551)
Registrant - CarePluss Pharma S.A. de C.V. (815061551)
Establishment
NameAddressID/FEIBusiness Operations
CarePluss Pharma S.A. de C.V.815061551manufacture(51439-005)

Revised: 3/2013
Document Id: 49d3fb03-dee3-45de-b2ec-caf1443bafd2
Set id: b8c2e122-a386-4cfe-8072-cd686be995ce
Version: 2
Effective Time: 20130320
 
CarePluss Pharma S.A. de C.V.