CLARITY CLEAR SKIN ESSENTIALS DEEP-CLEANING ASTRINGENT- 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 Deep-Cleaning Astringent

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 skin irritation and dryness is more likely to occur if you use another topical acne medicationat the same time. 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 • clean skin thoroughly before applying this product • moisten a cotton ball, cover the entire affected area with a thin layer 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 allantoin, aloe barbadensis leaf juice powder, butylene glycol, camellia oleifera (green tea) leaf extract, chamomillia recuttia (matricaria) flower extract, fragrance, hamamelia virginiana (witch hazel) extract, melaleuca alternifolia (tea tree) leaf oil, menthol panthenol, pentylene glycol, polyquaternium-7 propandiol, PPG-5-ceteth-20, SD alcohol 40-B, sodium citrate, water, zinc PCA

Drug Fact Panel

CLARITY CLEAR SKIN ESSENTIALS DEEP-CLEANING ASTRINGENT
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:54473-221
Route of Administration	Topical	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (SALICYLIC ACID)	SALICYLIC ACID	0.623 g in 130 mL

Ingredient Name	Strength
Inactive Ingredients
BUTYLENE GLYCOL
CAMELLIA OLEIFERA LEAF
CHAMOMILE
HAMAMELIS VIRGINIANA TOP
MENTHOL
PANTHENOL
PENTYLENE GLYCOL
PPG-5-CETETH-20
PROPANEDIOL
SODIUM CITRATE
WATER
ZINC PIDOLATE

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54473-221-04	130 mL in 1 BOTTLE, PLASTIC

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

Labeler - Melaleuca, Inc. (139760102)

Registrant - Melaleuca, Inc. (139760102)

Name	Address	ID/FEI	Business Operations
Establishment
Melaleuca, Inc.		787086842	manufacture(54473-221)

Revised: 3/2013

Document Id: a29a7caf-f9d2-47b4-bc80-fb165118b872

Set id: a665ab62-e1b5-4e7a-b015-f447e5412584

Version: 1

Effective Time: 20130304

Melaleuca, Inc.