LEROSETT High-Content Organic Acne Treatment Botanically Based: Package Insert and Label Information

LEROSETT HIGH-CONTENT ORGANIC ACNE TREATMENT BOTANICALLY BASED- salicylic acid gel
Cosmetic Specialty labs, Inc.

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.

ACTIVE INGREDIENT

Salicylic Acid 2%

PURPOSE

Acne Treatment

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a poison control center right away.

USES

for treatment of acne

WARNINGS

for external use only

Ask a doctor if you are using other topical acne medications at the same time or immediately following use of this product. If increased dryness or irrritation occurs, only one medication should be used, unless directed by a doctor.

Avoid contact with eyes. If contact occurs, flush thoroughly with water.

DIRECTIONS

Use twice a day. Wet face, apply to hands, add water and work: into a lather. Massage into your face, rinse.

INACTIVE INGREDIENTS

Aloe Barbadensis Leaf, Caprylyl GIycol, Cocamidopropyl Betaine, Coco-Glucoside, Fragrance, Glyceryl Oleate, Lauramide DEA, Lauryl Glucoside, Phenoxyethanol, Purified Water, Sodium Citrate, Sodium Lauryl Glucose Carboxylate.

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LEROSETT HIGH-CONTENT ORGANIC ACNE TREATMENT BOTANICALLY BASED
salicylic acid gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58133-062
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
CAPRYLYL GLYCOL
COCAMIDOPROPYL BETAINE
COCO GLUCOSIDE
GLYCERYL OLEATE
LAURIC DIETHANOLAMIDE
LAURYL GLUCOSIDE
PHENOXYETHANOL
WATER
SODIUM CITRATE
SODIUM LAURYL GLYCOL CARBOXYLATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58133-062-67 200 mL in 1 BOTTLE None
2 NDC:58133-062-13 385 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 01/01/2013
Labeler — Cosmetic Specialty labs, Inc. (032973000)
Establishment
Name Address ID/FEI Operations
Cosmetic Specialty labs, Inc. 032973000 manufacture (58133-062)

Revised: 01/2013 Cosmetic Specialty labs, Inc.

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