ACNE CLEARNING TREATMENT FACE- sulfur, benzoyl peroxide, salicylic acid 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 Ingredient....................................Purpose
Sulphur 5%...............................................Acne medication
Benzoyl Peroxide 2.5%...............................Acme medication
Salicylic acid 2%........................................Acne medication

Uses:For the management of acne

Warnings: For external use only.

Do not use

When using this product
Stop use and ask a doctor if
irritation becomes severe

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

Directions:
  1. Acne Clearing Cleanser
  2. Acne Clearing Tonic
  3. Acne Clearing Treatment 101

Ingredients: Purified Water, Ethyl Alcohol, Hamammelis Extract, Chamomile Extract, Salicyl Alcohol, Ethhylene Glycol, Propylene Glycol, Dodecyl Benzene Sulfonate, EDTA, Methylparaben, Propylparaben. 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.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.

Three Bottles
  1. Acne Clearing Cleanser 240 mL
  2. Acne Clearing Tonic 120 mL
  3. Acne Clearing Treatment 101 60 mL

labels
Acne Clearing Treatment - FACE
ACNE CLEARNING TREATMENT  FACE
sulfur, benzoyl peroxide, salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51439-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR.012 mg  in .024 mg
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE.006 mg  in .024 mg
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID.0048 mg  in .024 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CATALINA (UNII: T3JI0587Q7)  
ARNICA MONTANA (UNII: O80TY208ZW)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETEARETH-12 (UNII: 7V4MR24V5P)  
BROMELAINS (UNII: U182GP2CF3)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
MINERAL OIL (UNII: T5L8T28FGP)  
ETHYLENE GLYCOL (UNII: FC72KVT52F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
TROLAMINE (UNII: 9O3K93S3TK)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PIPERINE (UNII: U71XL721QK)  
MINT (UNII: FV98Z8GITP)  
EDETIC ACID (UNII: 9G34HU7RV0)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
VITAMIN A (UNII: 81G40H8B0T)  
POMEGRANATE (UNII: 56687D1Z4D)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51439-007-023 in 1 BOX
1NDC:51439-007-01.024 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(51439-007)

Revised: 3/2013
Document Id: d08e6fbf-9162-47cd-9cf6-74ea24d48214
Set id: 0001eaa9-e890-4e94-9d44-47a0f3086a02
Version: 2
Effective Time: 20130320
 
CarePluss Pharma S.A. de C.V.