The Skincare Co - BPT3.1 ACNE TREATMENT (71792-102) - DELIST

BPT3.1 ACNE TREATMENT by

Drug Labeling and Warnings

BPT3.1 ACNE TREATMENT by is a Otc medication manufactured, distributed, or labeled by THE SKINCARE COMPANY, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BPT3.1 ACNE TREATMENT- benzoyl peroxide lotion 
THE SKINCARE COMPANY, INC.

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The Skincare Co - BPT3.1 ACNE TREATMENT (71792-102) - DELIST

ACTIVE INGREDIENT

BENZOYL PEROXIDE 3%

PURPOSE

ACNE TREATMENT

USE

FOR THE TREATMENT OF ACNE.

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE IF YOU:

  • HAVE VERY SENSITIVE SKIN.
  • ARE SENSITIVE TO BENZOYL PEROXIDE.

WHEN USING THIS PRODUCT

  • 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.
  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN.
  • AVOID CONTACT WITH THE EYES, LIPS, AND MOUTH.
  • AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THIS PRODUCT.
  • SKIN IRRITATION MAY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING, OR POSSIBLY SWELLING. IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION.

STOP USE AND ASK A DOCTOR IF

  • IRRITATION BECOMES SEVERE.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

SENSITIVITY TEST FOR A NEW USER.
APPLY PRODUCT SPARINGLY TO ONE OR TWO SMALL AFFECTED AREAS DURING THE FIRST 3 DAYS. IF NO DISCOMFORT OCCURS, FOLLOW THE DIRECTIONS STATED BELOW.
CLEAN THE 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.
IF GOING OUTSIDE, APPLY SUNSCREEN AFTER USING THIS PRODUCT. IF IRRITATION OR SENSITIVITY DEVELOPS, STOP USE OF BOTH PRODUCTS AND ASK A DOCTOR.

OTHER INFORMATION

  • ORGANIC INGREDIENTS ARE DENOTED WITH THE *.

INACTIVE INGREDIENTS

WATER, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*, EMULSIFYING WAX NF, HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER, MACADAMIA TERNIFOLIA (MACADAMIA NUT) SEED OIL*, SODIUM PCA, STEARIC ACID, BUTYROSPERMUM PARKII (SHEA) BUTTER*, GLYCERIN, PHENOXYETHANOL, CAPRYLYL GLYCOL, SORBIC ACID, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL*, ALLANTOIN, SCLEROTIUM GUM.

01b UC_BPT3 1.5625x4.75 2.14.19

BPT3.1 ACNE TREATMENT 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71792-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
JOJOBA OIL (UNII: 724GKU717M)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
WITCH HAZEL (UNII: 101I4J0U34)  
MACADAMIA OIL (UNII: 515610SU8C)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SHEA BUTTER (UNII: K49155WL9Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SORBIC ACID (UNII: X045WJ989B)  
TEA TREE OIL (UNII: VIF565UC2G)  
ALLANTOIN (UNII: 344S277G0Z)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71792-102-1164 mL in 1 TUBE; Type 0: Not a Combination Product07/27/202008/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00607/27/202008/18/2020
Labeler - THE SKINCARE COMPANY, INC. (314521346)

Revised: 1/2024