CLARITY CLEAR SKIN ESSENTIALS FOAMING CLEANSER- salicylic acid liquid

Clarity Clear Skin Essentials by

Drug Labeling and Warnings

Clarity Clear Skin Essentials by is a Otc medication manufactured, distributed, or labeled by Melaleuca, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic acid 0.5%

Purpose

Acne Treatment

INDICATIONS & USAGE

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

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLARITY CLEAR SKIN ESSENTIALS  FOAMING CLEANSER
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-222
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.691 g  in 133 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CUCUMBER (UNII: YY7C30VXJT)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TEA TREE OIL (UNII: VIF565UC2G)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-222-04	133 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/13/2012

Labeler - Melaleuca, Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca, Inc.		079711683	manufacture(54473-222)