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LEROSETT High-Content Organic Acne Treatment Botanically Based

Medically reviewed on January 24, 2018

Dosage form: gel
Ingredients: SALICYLIC ACID 2g in 100mL
Labeler: Cosmetic Specialty labs, Inc.
NDC Code: 58133-062

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.

PRINCIPAL DISPLAY PANEL

LEROSETT HIGH-CONTENT ORGANIC ACNE TREATMENT  BOTANICALLY BASED
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-062
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage Description
1NDC:58133-062-67200 mL in 1 BOTTLE
2NDC:58133-062-13385 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/2013
Labeler - Cosmetic Specialty labs, Inc. (032973000)
Establishment
NameAddressID/FEIOperations
Cosmetic Specialty labs, Inc.032973000manufacture(58133-062)

 
Cosmetic Specialty labs, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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