FDA.reportPublic FDA data

Caring mill Acne Treatment

Manufacturer
FSA Store Inc.
Effective date
2024-01-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:07:36

Label at a glance#

ProductCaring mill Acne Treatment
Active ingredientBENZOYL PEROXIDE
Label structure7 sections

Dosage and administration

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 applicaiton to once a day or every other day  If going outside, apply...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 10%

Purpose

OTC - PURPOSE SECTION

Acne medication

Use

INDICATIONS & USAGE SECTION

For the management of acne.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same timr. If irritation occurs, only use one topical acne medication at a time
  • Avoid unnecessary sun exposure and use sunscreen
  • Avoid contact with the eyes, lips, and mouth. If contact occurs, flush thorughly with water.
  • Avoid contact with hair and dyed products, 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.

Do not use if you

OTC - DO NOT USE SECTION

  • have very sensitive skin
  • are sensitive to benzoyl peroxide.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation becomes severe.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 applicaiton to once a day or every other day 
  • If going outside, apply sunscreen after using this product. If irritaion or sensitivity develops, stop use of both products and ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

Protect from excessive heat (104°F/40°C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Polyacrylate Crosspolymer-11, Laureth-4, Hydroxypropyl Methylcellulose, Silica, Methicone, Sodium Hydroxide, Disodium EDTA.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package2Outer Package2Inner Package2Inner Package2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106315benzoyl peroxide 10 % Topical CreamPSN1
106315benzoyl peroxide 100 MG/ML Topical CreamSCD1
106315benzoyl peroxide 10 % Topical CreamSY1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81522-951-01Caring mill Acne Treatment28 g in 1 TUBECREAM281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81522-951CARING MILL ACNE TREATMENT (BENZOYL PEROXIDE) CREAM [FSA STORE INC.]1Current NDC, 1 package rows20240120_0ec20ba4-9251-fbb3-e063-6394a90a2ad6.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81522-95181522-951-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
AMMONIUM ACRYLOYL DIMETHYLTAURATE/METHACRYLATE, DIMETHYLACRYLAMIDE AND METHACRYLIC ACID COPOLYMER, PPG-3 GLYCERYL TRIACRYLATE CROSSLINKED (100000 MW)WR7H9IW2XXIACT
LAURETH-46HQ855798JIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
METHICONE (20 CST)6777U11MKTIACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

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
Caring mill Acne TreatmentBENZOYL PEROXIDEFSA Store Inc.0ec20ba4-9251-fbb3-e063-6394a90a2ad62024-01-12WarningsExact identifier
ndc (package): 81522-951-01
ndc (product): 81522-951
ndc11 (package): 81522095101
spl id: 0ec20ce2-cd8e-4d1c-e063-6294a90a83b0
spl set id: 0ec20ba4-9251-fbb3-e063-6394a90a2ad6

Reported adverse events (FAERS/openFDA)#

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