FDA.reportPublic FDA data

Vichy Laboratoires Normaderm BHA Exfoliating Acne Treatment

Manufacturer
COSMETIQUE ACTIVE PRODUCTION | Interspray
Effective date
2023-12-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:03:54

Label at a glance#

ProductVichy Laboratoires Normaderm BHA Exfoliating Acne Treatment
Active ingredientSALICYLIC ACID
Label structure11 sections

Indications and uses

for the treatment of acne clears acne blemishes and allows skin to heal helps prevent new acne blemishes

Dosage and administration

cleanse the skin thoroughly before applying this product cover the entire affected area with a thin layer one to three times daily because too much 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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 1%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

  • for the treatment of acne
  • clears acne blemishes and allows skin to heal
  • helps prevent new acne blemishes

Warnings

WARNINGS SECTION

For external use only

Flammable until dry.

SAFE HANDLING WARNING SECTION

Keep away from flames and heat.

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

  • cleanse the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because too much 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol denat., hydroxyethylpiperazine ethane sulfonic acid, glycolic acid, glycerin, propanediol, sodium hydroxide, PEG/PPG/polybutylene glycol-8/5/3 glycerin, sodium polyacrylate, adenosine, ammonium polyacryloyldimethyl taurate, ascorbyl glucoside, vitreoscilla ferment, trisodium ethylenediamine disuccinate, xanthan gum, panthenol, menthol

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-37-VICHY (84249)

Monday – Friday (9 a.m. to 5 p.m. EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a carton

image of a carton
image of a carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69625-231-01Vichy Laboratoires Normaderm BHA Exfoliating Acne Treatment30 mL in 1 BOTTLELOTION302
69625-231-01Vichy Laboratoires Normaderm BHA Exfoliating Acne Treatment1 in 1 CARTONLOTION12
69625-231-02Vichy Laboratoires Normaderm BHA Exfoliating Acne Treatment3 mL in 1 TUBELOTION32
69625-231-02Vichy Laboratoires Normaderm BHA Exfoliating Acne Treatment1 in 1 CARTONLOTION12
69625-231-03Vichy Laboratoires Normaderm BHA Exfoliating Acne Treatment5 mL in 1 TUBELOTION52
69625-231-03Vichy Laboratoires Normaderm BHA Exfoliating Acne Treatment1 in 1 CARTONLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69625-231VICHY LABORATOIRES NORMADERM BHA EXFOLIATING ACNE TREATMENT (SALICYLIC ACID) LOTION [COSMETIQUE ACTIVE PRODUCTION]2Current NDC, 6 package rows20231212_a2369870-cf81-4ebd-a354-858212d67d0e.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
69625-23169625-231-01, 69625-231-02, 69625-231-03

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACIDRWW266YE9IIACT
GLYCOLIC ACID0WT12SX38SIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
ADENOSINEK72T3FS567IACT
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S)F01RIY4371IACT
ASCORBYL GLUCOSIDE2V52R0NHXWIACT
VITREOSCILLA LYSATE68DV8T89Y2IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
XANTHAN GUMTTV12P4NEEIACT
PANTHENOLWV9CM0O67ZIACT
MENTHOLL7T10EIP3AIACT

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
Vichy Laboratoires Normaderm BHA Exfoliating Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONa2369870-cf81-4ebd-a354-858212d67d0e2023-12-11WarningsExact identifier
ndc (package): 69625-231-01
ndc (package): 69625-231-03
ndc (package): 69625-231-02
ndc (product): 69625-231
ndc11 (package): 69625023101
ndc11 (package): 69625023102
ndc11 (package): 69625023103
spl id: 57f0b452-ea26-4d24-b1ae-8f18320959ee
spl set id: a2369870-cf81-4ebd-a354-858212d67d0e

Reported adverse events (FAERS/openFDA)#

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