Label: CLARITY CLEAR SKIN ESSENTIALS ACNE TREATMENT- salicylic acid cream
- NDC Code(s): 54473-295-01
- Packager: Melaleuca Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated March 19, 2020
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- Active ingredient
- INDICATIONS & USAGE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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
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)