BPT10.1 ACNE TREATMENT

Manufacturer
Create Cosmetics, LLC
Effective date
2024-01-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:50

Label at a glance#

ProductBPT10.1 ACNE TREATMENT
Active ingredientBENZOYL PEROXIDE
Label structure9 sections

Dosage and administration

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 INC...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

BENZOYL PEROXIDE 10%

PURPOSE

OTC - PURPOSE SECTION

ACNE TREATMENT

USE

INDICATIONS & USAGE SECTION

FOR THE TREATMENT OF ACNE.

WARNINGS

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

  • ORGANIC INGREDIENTS ARE DENOTED WITH THE *.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b UC_BPT10 1.5625x4.75 8.20.1801b UC_BPT10 1.5625x4.75 8.20.18

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106310benzoyl peroxide 10 % Topical LotionPSN2
106310benzoyl peroxide 100 MG/ML Topical LotionSCD2
106310benzoyl peroxide 10 % Topical LotionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70162-103-512024-07-30C16284748780-11e7a6dab-1755-a2ce-e063-dadaa90aadf7CREATE COSMETICS - BPT10.1 ACNE TREATMENT (70162-103)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70162-103-11BPT10.1 ACNE TREATMENT64 mL in 1 TUBELOTION642
70162-103-51BPT10.1 ACNE TREATMENT1 in 1 BOXLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70162-103BPT10.1 ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [CREATE COSMETICS, LLC]2Legacy NDC, 2 package rows20240108_d91e383f-44d4-03e9-e053-2a95a90a2770.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70162-10370162-103-11, 70162-103-51

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0e5e208a-01b5-acda-e063-6394a90aee16d91e383f-44d4-03e9-e053-2a95a90a27702024-01-07WarningsExact identifier
spl id: 0e5e208a-01b5-acda-e063-6394a90aee16
spl set id: d91e383f-44d4-03e9-e053-2a95a90a2770

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.