caring mill Acne Spot Treatment

Manufacturer
Clixit, Llc
Effective date
2021-06-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:02

Label at a glance#

Productcaring mill Acne Spot Treatment
Active ingredientSULFUR
Label structure8 sections

Dosage and administration

• Clean the skin thoroughly before using • Apply a thin layer to entire affected area • 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 of peeling occurs, reduce application to once a day or every other day

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sulfur 10%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use:

INDICATIONS & USAGE SECTION

For the treatment of acne

Warnings:

WARNINGS SECTION

For external use only.

When using this product
• Do not use on broken skin or large areas of skin
• Apply only to areas with acne
• 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
• Stop use and ask a doctor if skin irritation occurs or gets worse
• Rinse right away with water if product gets in eyes

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

• Clean the skin thoroughly before using
• Apply a thin layer to entire affected area
• 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 of peeling occurs, reduce application to once a day or every other day

Other Ingredients:

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Camphor, Carbomer, Isopropyl Alcohol, Phenoxyethanol, Propylene Carbonate, Salicylic Acid, Tetrasodium EDTA, Triethanolamine, Zinc Oxide.

SPL UNCLASSIFIED SECTION

HELPS CLEAR BLEMISHES FAST

Benefits

• Reduces redness and swelling

• Controls oil production

• Allows skin to heal

• Unblocks clogged pores

• Prevents new breakouts

• Will not cause redness or irritation

Results may vary

Maximum sulfur 10% penetrates pores to control acne

Camphor instantly cools and calms inflamed skin

Salicylic acid unblocks pores and sheds dead skin cells for faster healing

NOT TESTED ON ANIMALS

Made in the USA

Manufactured for FSA Store Inc.
240 W 37th St. 6th Floor
New York, NY 10018
Customer Help Line:
(844) 425-4948

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acne62Acne62

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
315220sulfur 10 % Topical CreamPSN1
315220sulfur 100 MG/ML Topical CreamSCD1
315220sulfur 10 % Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71328-062-022024-01-30C16284748780-11030e365-2486-111a-e063-dadaa90a10e2caring mill™ Acne Spot Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71328-062-01caring mill Acne Spot Treatment15 mL in 1 TUBECREAM151
71328-062-02caring mill Acne Spot Treatment1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71328-062CARING MILL ACNE SPOT TREATMENT (SULFUR) CREAM [CLIXIT, LLC]1Legacy NDC, 2 package rows20210624_f62000e3-e720-4283-8a00-a60f07747506.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71328-06271328-062-01, 71328-062-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
cef6069f-0f1e-497b-9718-315ef734aa4ff62000e3-e720-4283-8a00-a60f077475062021-06-21WarningsExact identifier
spl id: cef6069f-0f1e-497b-9718-315ef734aa4f
spl set id: f62000e3-e720-4283-8a00-a60f07747506

Reported adverse events (FAERS/openFDA)#

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