Label: BUTT AND THIGHS ACNE TREATMENT- salicylic acid cream
- NDC Code(s): 82767-002-04
- Packager: Teamtrade Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated October 13, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USE:
- WARNINGS
- WHEN USING
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DIRECTIONS:
Clean the skin thoroughly before applying product.
Cover the entire affected area with a thin layer one to three times daily.
Because excess 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.
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- SAFE HANDLING WARNING
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INACTIVE INGREDIENT
Aqua, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Caprylic/Capric Triglyceride, Beeswax, Glycerin, Polyglyceryl-6 Palmitate/Succinate, Cetearyl Alcohol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Cetyl Alcohol, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Organic Butyrospermum Parkii (Shea) Butter, Dimethicone, Dimethicone Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Parfum, Sodium Hydroxide, Xanthan Gum, Disodium EDTA, Rosmarinus Officinalis (Rosemary) Extract, Tocopheryl Acetate, Mentha Piperita (Peppermint) Oil, Salix Alba Bark Extract, Camellia Sinensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Hexyl Cinnamal, D-Limonene, Linalool, Benzyl Salicylate, Benzyl Alcohol, Citral.
- BUTT & THIGHS ACNE TREATMENT CREAM 4oz (Label - Box)
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INGREDIENTS AND APPEARANCE
BUTT AND THIGHS ACNE TREATMENT
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82767-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 mL Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE (UNII: 92RU3N3Y1O) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ALMOND OIL (UNII: 66YXD4DKO9) CETYL ALCOHOL (UNII: 936JST6JCN) SHEA BUTTER (UNII: K49155WL9Y) XANTHAN GUM (UNII: TTV12P4NEE) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) LAURETH-7 (UNII: Z95S6G8201) GLYCERIN (UNII: PDC6A3C0OX) CAPRYLYL GLYCOL (UNII: 00YIU5438U) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) HEXYLENE GLYCOL (UNII: KEH0A3F75J) LIMONENE, (+)- (UNII: GFD7C86Q1W) ALOE VERA LEAF (UNII: ZY81Z83H0X) TEA TREE OIL (UNII: VIF565UC2G) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PEG-8 BEESWAX (UNII: 3C1QUF1TIR) GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947) SODIUM HYDROXIDE (UNII: 55X04QC32I) ROSEMARY (UNII: IJ67X351P9) PEPPERMINT OIL (UNII: AV092KU4JH) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) LINALOOL, (+/-)- (UNII: D81QY6I88E) BENZYL SALICYLATE (UNII: WAO5MNK9TU) BENZYL ALCOHOL (UNII: LKG8494WBH) CITRAL (UNII: T7EU0O9VPP) SALIX ALBA BARK (UNII: 205MXS71H7) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82767-002-04 118.3 mL in 1 TUBE; Type 0: Not a Combination Product 09/22/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 09/22/2022 Labeler - Teamtrade Inc. (067321781)