BUTT AND THIGHS ACNE TREATMENT- salicylic acid cream 
Teamtrade 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.

----------

82767-002-04

Salicylic Acid 2%

Purpose: Acne treatment

USE:

For the treatment of acne.

For external use only.

Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

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.

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding, ask a health professional before use.

Protect the product in this container from excessive heat and direct sun.

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)

BUTT & THIGHS 4oz

BUTT AND THIGHS  ACNE TREATMENT
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82767-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82767-002-04118.3 mL in 1 TUBE; Type 0: Not a Combination Product09/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00609/22/2022
Labeler - Teamtrade Inc. (067321781)

Revised: 10/2022
Document Id: eaebf4b4-ba4d-15ad-e053-2a95a90ab5ac
Set id: e94a3d17-564f-3e64-e053-2995a90aa402
Version: 2
Effective Time: 20221013
 
Teamtrade Inc.