CLARITY CLEAR SKIN ESSENTIALS ACNE SPOT TREATMENT- salicylic acid cream
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 Acne Spot Treatment

Active Ingredient

Salicylic acid 2.0%

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 top occur if you use another topical acne medication at the same time. If this occurs, only one acne 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 • 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 butylene glycol, fragrance, hamamalis virginiana (witch hazel) extract, hydroxypropyl beta cyclodextrin, melaleuca alternifolia (tea Tree) leaf oil, menthol, SD alcohol 40-B, water

clarityspot

CLARITY CLEAR SKIN ESSENTIALS ACNE SPOT TREATMENT
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:54473-225
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (SALICYLIC ACID)	SALICYLIC ACID	.156 g in 8.9 mL

Ingredient Name	Strength
Inactive Ingredients
WATER
HAMAMELIS VIRGINIANA TOP
BUTYLENE GLYCOL
MENTHOL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54473-225-01	8.9 mL in 1 BOTTLE, WITH APPLICATOR

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(54473-225)

Revised: 3/2013

Document Id: d985b17d-794a-4587-a670-baf65cc03996

Set id: df33b7ba-f2b2-4031-8b27-9d0b27e256fe

Version: 1

Effective Time: 20130304

Melaleuca Inc.