Label: TONIC ACNE CLEARING TREATMENT- salicylic acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 51439-006-01 - Packager: CarePluss Pharma S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 20, 2013
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- ACTIVE INGREDIENT
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PURPOSE
Uses:For the management of acne
- helps clear up acne blemishes, black heads, helps prevent the development of new acne pimples
- penetrates pores to reduce the number of acne pimples, white heads and black heads
- help keep skin clear of new acne pimples, white heads and black heads
- helps prevent new acne pimples, white heads and black heads from forming
- help prevent the development of new pimples, white heads and black heads
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WARNINGS
Warnings: For external use only.
Do not use
- if you have sensitive skin and/or are sensitive to Salicylic acid
- skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
- avoid unnecessary sun exposure and use sun screen, Acne Clearing Moisture with SPF 45
- skin irritation may occur, characterized by redness, burning, itching, peeling, and possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration
- irritation becomes severe
- if you have sensitive skin and/or are sensitive to Salicylic acid
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions:
- cleanse skin with ACNE CLEARING CLEANSER a benzoyl peroxide acne medication cleansing gel.
- moisten fresh cotton ball with ACNE CLEARING TONIC a salicylic acid serum medication for oil control.
- apply on entire face.
- start with one application daily then gradually increase to 2 or 3.
- if going outside after cleansing apply sun screen, Acne Clearing Moisture with SPF 45
- if excessive irritation or sensitivity develops stop use of both products and contact a physician.
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TONIC ACNE CLEARING TREATMENT
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51439-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID .0024 mg in .120 mg Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:51439-006-01 .120 mg in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 08/06/2012 Labeler - CarePluss Pharma S.A. de C.V. (815061551) Registrant - CarePluss Pharma S.A. de C.V. (815061551) Establishment Name Address ID/FEI Business Operations CarePluss Pharma S.A. de C.V. 815061551 manufacture(51439-006)
