CLARITY CLEAR SKIN ESSENTIALS ACNE TREATMENT- salicylic acid cream

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 2.0%

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

When using this product skin irritaion and dryness is more likely to occur if you use another topical acne medication at the same time. If this occurs, only one medication should be used unless otherwise directed by a doctor.

STOP USE

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 ■ 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

STORAGE AND HANDLING

Other information store at room temperature between 40°F and 90°F

INACTIVE INGREDIENT

Inactive ingredients cetyl alcohol, cetearyl alcohol, ethylhexyl palmitate, glyceryl stearate, hydroxypropyl beta cyclodextrin, melaleuca alternifolia (tea tree) leaf oil, peg-100 stearate, polyglyceryl-3 methylglucose distearate, polysorbate 60, steareth-2, steareth-21, stearic acid, triethanolamine, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLARITY CLEAR SKIN ESSENTIALS  ACNE TREATMENT
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-295
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.28 g  in 14 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
STEARIC ACID (UNII: 4ELV7Z65AP)
TEA TREE OIL (UNII: VIF565UC2G)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-295-01	14 g in 1 TUBE; 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)

Registrant - Melaleuca Inc. (079711683)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca Inc.		079711683	manufacture(54473-295)