Label: BPT10.1 ACNE TREATMENT- benzoyl peroxide lotion
- NDC Code(s): 70162-103-11, 70162-103-51
- Packager: Create Cosmetics, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 7, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USE
-
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
-
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
-
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.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BPT10.1 ACNE TREATMENT
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70162-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:70162-103-51 1 in 1 BOX 07/27/2020 1 NDC:70162-103-11 64 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 07/27/2020 Labeler - Create Cosmetics, LLC (057569916)
