FDA.reportPublic FDA data

Salicylic Acid Acne Removal Cleanser

Manufacturer
COMFMET LIMITED
Effective date
2024-10-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:24:41

Label at a glance#

ProductSalicylic Acid Acne Removal Cleanser
Active ingredientSALICYLIC ACID
Label structure14 sections

Indications and uses

Treats acne - dries up acne - help prevent new acne

Dosage and administration

gently massage cleanser onto skin and remove with lukewarm water.use once daily，if bothersome dryness or peeling occurs, reduce application to every other day.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 0.05%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

Treats acne - dries up acne - help prevent new acne

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on the broken skin - if pregnant or lactating

When Using

OTC - WHEN USING SECTION

avoid unnecessary sun exposure and use a sunscreen.
do not use in or near the eyes.
not that using other topical acne drugs at the same time or right after use of this product may increase dryness or skin irritation.

Stop Use

OTC - STOP USE SECTION

Stop useand ask a doctor if too much skin irritation or sensitivity develops or increase.

Ask Doctor

OTC - ASK DOCTOR SECTION

Stop useand ask a doctor if too much skin irritation or sensitivity develops or increase.

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

INDICATIONS & USAGE SECTION

gently massage cleanser onto skin and remove with lukewarm water.use once daily，if bothersome dryness or peeling occurs, reduce application to every other day.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water
glycerin
palmitidacid
stearic acid
myristic acid
potassium hydroxide
lauric acid
potassium cocoyl glycinate
ceteareth-30
behenyl alcohol
potassium chloride
ceteareth-29
hydroxypropyl methylcelulose
ceteareth-33
methylparaben
dmdm hydantoin
propylparaben
disodium edta
fragrance
acacia senegal gum

OTC - QUESTIONS SECTION


Email: commet515@gmail.com

DOSAGE & ADMINISTRATION SECTION

use once daily，if bothersome dryness or peeling occurs, reduce application to every other day

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ximiannaoiximiannaoi

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
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816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84766-0002-12025-07-29C16284748780-13b156c62-2c7f-fb37-e063-e6dba90a4e07244314ec-6247-a8e3-e063-6394a90a48ec

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84766-0002-1Salicylic Acid Acne Removal Cleanser100 g in 1 TUBECREAM1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84766-0002SALICYLIC ACID ACNE REMOVAL CLEANSER CREAM [COMFMET LIMITED]11 package rows20241015_244314ec-6247-a8e3-e063-6394a90a48ec.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84766-000284766-0002-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARIC ACID4ELV7Z65APIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
BEHENYL ARACHIDATE3SAW92S93GIACT
POTASSIUM CHLORIDE660YQ98I10IACT
CETEARETH-2730JD5RDD6RIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM COCOYL GLYCINATEWZ70FUF22UIACT
POTASSIUM CHLORATEH35KS68EE7IACT
MYRISTIC ACID0I3V7S25AWIACT
CETEARETH-301R9DCZ5FOXIACT
METHYLPARABENA2I8C7HI9TIACT
DISODIUM EDTA-COPPER6V475AX06UIACT
ACACIA SENEGAL FLOWER72P931MTC2IACT
WATER059QF0KO0RIACT
DMDM HYDANTOINBYR0546TOWIACT
LAURIC ACID1160N9NU9UIACT
PROPYLPARABENZ8IX2SC1OHIACT
SALICYLIC ACIDO414PZ4LPZACTIB
PALMITIC ACID2V16EO95H1IACT
BUTYL METHACRYLATE/ETHYLHEXYL ACRYLATE/METHACRYLIC ACID/DIMETHYLAMINOETHYL METHACRYLATE/STYRENE/HYDROXYPROPYL METHACRYLATE COPOLYMER (60000 MW)B2U8V9E232IACT
CETEARETH-33R42C2O714BIACT
FRAGRANCE 135765EM498GW35IACT

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
244314ec-6248-a8e3-e063-6394a90a48ec244314ec-6247-a8e3-e063-6394a90a48ec2024-10-12WarningsExact identifier
spl id: 244314ec-6248-a8e3-e063-6394a90a48ec
spl set id: 244314ec-6247-a8e3-e063-6394a90a48ec

Reported adverse events (FAERS/openFDA)#

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