TONIC ACNE CLEARING TREATMENT- 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 Ingredients:                      Purpose:
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

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

Directions:

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

2 FL OZ / 60 ml

label
Tonic
Acne Clearing Treatment
TONIC  ACNE CLEARING TREATMENT
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51439-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID.0024 mg  in .120 mg
Inactive Ingredients
Ingredient NameStrength
DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9)  
ALCOHOL (UNII: 3K9958V90M)  
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
ARNICA MONTANA (UNII: O80TY208ZW)  
ETHYLENE GLYCOL (UNII: FC72KVT52F)  
VITAMIN A (UNII: 81G40H8B0T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9)  
EDETIC ACID (UNII: 9G34HU7RV0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51439-006-01.120 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(51439-006)

Revised: 3/2013
Document Id: 9b4b6abd-2b57-42a9-9d48-4c625358ebd5
Set id: 213fab0c-eaf8-4a72-a50a-25e59f131993
Version: 2
Effective Time: 20130320
 
CarePluss Pharma S.A. de C.V.