CLEAR PROOF CLARIFYING CLEANSING GEL ACNE MEDICATION- salicylic acid gel

Clear Proof Clarifying Cleansing Gel by

Drug Labeling and Warnings

Clear Proof Clarifying Cleansing Gel by is a Otc medication manufactured, distributed, or labeled by Mary Kay Inc., Port Jervis Laboratories Inc., Englewood Lab Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic Acid (2% W/W)

Purpose

Acne Medication

Uses

• for the management of acne
• helps prevent new acne pimples

Warnings

For external use only

When using this product

• 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 contact with the eyes

Stop use and ask a doctor if

irritation or sensitivity develops or increases

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• cleanse skin thoroughly before applying medication
• cover the entire affected area with a thin layer and rinse thoroughly one to three times daily
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive ingredients

arctium lappa root extract, butylene glycol, citric acid, cocamidopropyl betaine, cystoseira amentacea/caespitosa branchycarpa extract, disodium EDTA, DMDM hydantoin, epilobium angustifolium flower/leaf/stem extract, ethylparaben, glycerin, methylparaben, phenoxyethanol, propylene glycol, propylparaben, sodium C14-16 olefin sulfonate, sodium chloride, triethanolamine, water

Principal Display Panel - 127 g carton

clearproof

clarifying cleansing gel

acne medication

2% salicylic acid

4.5 OZ. NET WT. / 127 g

Mary Kay

INGREDIENTS AND APPEARANCE

CLEAR PROOF CLARIFYING CLEANSING GEL  ACNE MEDICATION
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-1349
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 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C14 OLEFIN SULFONATE (UNII: N816E2SOKI)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GLYCERIN (UNII: PDC6A3C0OX)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-1349-4	1 in 1 CARTON	08/15/2013
1		127 g 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	part333D	08/15/2013

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-1349)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		081158134	manufacture(51531-1349)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Inc.		080987545	pack(51531-1349)