FDA.reportPublic FDA data

CeraVe Developed with Dermatologists Acne Control Cleanser

Manufacturer
Unette Corporation
Effective date
2024-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:15

Label at a glance#

ProductCeraVe Developed with Dermatologists Acne Control Cleanser
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

clears acne blemishes and allows skin to heal helps prevent new acne blemishes from forming

Dosage and administration

use twice daily shake well, wet face, then work product into a lather massage onto face avoiding the eyes rinse well

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 2%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

  • clears acne blemishes and allows skin to heal
  • helps prevent new acne blemishes from forming

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 time. if irritation occurs, only use one topical acne medication at a time.

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

  • use twice daily
  • shake well, wet face, then work product into a lather
  • massage onto face avoiding the eyes
  • rinse well

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sodium lauroyl sarcosinate, cocamidopropyl hydroxysultaine, glycerin, niacinamide, gluconolactone, sodium methyl cocoyl taurate, PEG-150 pentaerythrityl tetrastearate, xanthan gum, sodium benzoate, sodium hydroxide, hectorite, trisodium ethylenediamine disuccinate, sodium lauroyl lactylate, tetrasodium EDTA, calcium gluconate, ceramide NP, triethyl citrate, caprylyl glycol, ceramide AP, phytosphingosine, cholesterol, hydrolyzed hyaluronic acid, carbomer, benzoic acid, ceramide EOP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDPPDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN1
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD1
562600salicylic acid 2 % Facial Cleanser TonerSY1
562600salicylic acid 2 % Facial ScrubSY1
562600salicylic acid 2 % Medicated Liquid SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75897-112-01CeraVe Developed with Dermatologists Acne Control Cleanser10 mL in 1 TUBEGEL101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75897-112CERAVE DEVELOPED WITH DERMATOLOGISTS ACNE CONTROL CLEANSER (SALICYLIC ACID) GEL [UNETTE CORPORATION]11 package rows20240302_129b415c-43dd-daa0-e063-6394a90af57d.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75897-11275897-112-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
GLYCERINPDC6A3C0OXIACT
NIACINAMIDE25X51I8RD4IACT
GLUCONOLACTONEWQ29KQ9POTIACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
PEG-150 PENTAERYTHRITYL TETRASTEARATE8L4OOQ76AMIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM HYDROXIDE55X04QC32IIACT
HECTORITE08X4KI73EZIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
EDETATE SODIUMMP1J8420LUIACT
CALCIUM GLUCONATESQE6VB453KIACT
CERAMIDE NP4370DF050BIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CERAMIDE APF1X8L2B00JIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
CHOLESTEROL97C5T2UQ7JIACT
HYALURONIC ACIDS270N0TRQYIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
BENZOIC ACID8SKN0B0MIMIACT
CERAMIDE 15THT33P7X7IACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
129b0cb0-bf16-cefa-e063-6394a90a2f67129b415c-43dd-daa0-e063-6394a90af57d2024-03-01WarningsExact identifier
spl id: 129b0cb0-bf16-cefa-e063-6394a90a2f67
spl set id: 129b415c-43dd-daa0-e063-6394a90af57d

Reported adverse events (FAERS/openFDA)#

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