Clarity Clear Skin Essentials Acne Treatment Cream

Clarity Clear Skin Essentials Acne Treatment Cream

Drug Labeling and Warnings

Drug Details

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CLARITY CLEAR SKIN ESSENTIALS ACNE 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 Treatment Cream

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 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 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

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

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

tube label

CLARITY CLEAR SKIN ESSENTIALS  ACNE TREATMENT
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54473-295
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.28 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54473-295-0114 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/13/2012
Labeler - Melaleuca Inc. (139760102)
Registrant - Melaleuca Inc. (079711683)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca Inc.079711683manufacture(54473-295)

Revised: 2/2018
 
Melaleuca Inc.


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