CLARITY CLEAR SKIN ESSENTIALS FOAMING CLEANSER- salicylic acid liquid 
Melaleuca, 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.

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Clarity Clear Skin Essentials Foaming Cleanser

Active ingredient

Salicylic acid 0.5%

Purpose

Acne Treatment

Use for the treatment and management of acne

Warnings

For external use only. Do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

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

Stop use and ask a doctor if excessive irritation of the skin develops

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

Directions • cleanse skin twice a day on wet face • apply to hands, add water and work into a lather • massage face gently, rinse thoroughly • 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 aloe barbadensis leaf juice powder, butylene glycol, citric acid, cucumis sativas (cucumber) fruit extract, disodium cocoamphodlacetate, fragrance, melaleuca alternifolia (tea tree) leaf oil, sodium C14-16 olefin sulfate, sodium citrate, sodium methyl cocoyl taurate, sodium PCA, tetrasodium EDTA, water

Drug Fact Panel

CLARITY CLEAR SKIN ESSENTIALS  FOAMING CLEANSER
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54473-222
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID0.691 g  in 133 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF  
BUTYLENE GLYCOL 
CITRIC ACID MONOHYDRATE 
CUCUMBER 
DISODIUM COCOAMPHODIACETATE 
EDETATE SODIUM 
SODIUM C14-16 OLEFIN SULFONATE 
SODIUM METHYL COCOYL TAURATE 
SODIUM CITRATE 
SODIUM PYRROLIDONE CARBOXYLATE 
TEA TREE OIL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-222-04133 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/13/2012
Labeler - Melaleuca, Inc. (139760102)
Registrant - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc.787086842manufacture(54473-222)

Revised: 3/2013
Document Id: 3a839938-635e-4280-b667-f912335ef063
Set id: fb7ebe09-1b8d-4e20-9841-966ee9727e26
Version: 1
Effective Time: 20130304
 
Melaleuca, Inc.