CLEAR BLEMISH TREATMENT JAFRA- salicylic acid gel

Clear Blemish Treatment by

Drug Labeling and Warnings

Clear Blemish Treatment by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Salicylic Acid 2% Acne treatment Gel

Uses

treats acne

dries up acne pimples

helps prevent new acne pimples

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

When using this product

using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Warnings

For external use only

Directions

Clean the skin thoroughly before applying.

Cover the entire affected area with a thin layer 1 to 3 times daily.

Avoid contact with eyes

Because excessive drying of the skin may occur start with 1 application daily, then gradually increase to 2 or 3 times daily.

If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients: Acrylates/C10-30 Alkyl acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Denatonium Benzoate, Disodium Phosphate, Ethoxydiglycol, Eugenia Caryophyllus (clove) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Melia Azadirachta Extract, Panthenol, PPG-5 Ceteth-20, Propylene Glycol, Saccharide Isomerate, Salvia Sclarea (Clary) Oil, SD Alcohol 40-B/Alcohol Denat, Colloidal Sulfur, Water/Aqua, Xanthan Gum, Yeast Extract.

PRINCIPAL DISPLAY PANEL

Clear Blemish Treatment

Gel Facial De Control Expecializado

15 ml .5 Fl Oz US

INGREDIENTS AND APPEARANCE

CLEAR BLEMISH TREATMENT  JAFRA
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 151 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
CLOVE LEAF OIL (UNII: VCA5491KVF)
LAVENDER OIL (UNII: ZBP1YXW0H8)
AZADIRACHTA INDICA BARK (UNII: G580B439YI)
PANTHENOL (UNII: WV9CM0O67Z)
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
CLARY SAGE OIL (UNII: 87L0D4U3M0)
XANTHAN GUM (UNII: TTV12P4NEE)
YEAST (UNII: 3NY3SM6B8U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-129-02	1 in 1 BOX	06/19/2012
1	NDC: 68828-129-01	15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/19/2012

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-129)