BPT10.1 ACNE TREATMENT- benzoyl peroxide lotion

BPT10.1 ACNE TREATMENT by

Drug Labeling and Warnings

BPT10.1 ACNE TREATMENT by is a Otc medication manufactured, distributed, or labeled by Create Cosmetics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

BENZOYL PEROXIDE 10%

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BPT10.1 ACNE TREATMENT 
benzoyl peroxide lotion

Product 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)