FDA.reportPublic FDA data

Acne Reparatif

Manufacturer
RV Skincare LLC
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:27

Label at a glance#

ProductAcne Reparatif
Active ingredientSALICYLIC ACID
Label structure8 sections

Dosage and administration

clean the skin thoroughly before applying cover the entire affected area with a thin layer 1 to 3 times daily. Avoid eye area.  as excess drying of the skin may occur, begin with 1 application daily then increase to 2 or 3 times daily, if needed, or as directed by a physician if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 0.5%

Purpose

OTC - PURPOSE SECTION

Acne Medication

Use

INDICATIONS & USAGE SECTION

For the treatment of acne

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • apply to affected areas only
  • using other topical acne medication at the same time may increase dryness or irritation of the skin. If irritation occurs, use only one 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

  • clean the skin thoroughly before applying
  • cover the entire affected area with a thin layer 1 to 3 times daily. Avoid eye area. 
  • as excess drying of the skin may occur, begin with 1 application daily then increase to 2 or 3 times daily, if needed, or as directed by a physician
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Other information

SPL UNCLASSIFIED SECTION

Protect container from heat and flame. Do not smoke when applying this product. Keep container tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Alcohol Denat., Cyclopentasiloxane, PVM/MA Decadiene Crosspolymer, Dimethicone, Oligopeptide-10, sh-Oligopeptide-1, Phenoxyethanol, PPG-26-Buteth-26, Sodium Hydroxide, Butylene Glycol, Panthenol, PEG-40 Hydrogenated Castor Oil, Polysilicone-11,  Saccharomyces Lysate Extract, Glycerin, Caprylyl Glycol, Chlorphenesin, Decyl Glucoside, Avena Sativa (Oat) Kernel Extract, Hexylene Glycol, Potassium Sorbate, Citrus Aurantium Dulcis (Orange) Peel Oil, Citric Acid, Pantolactone, Limonene.

Questions or comments?

OTC - QUESTIONS SECTION

Call , M - F 8am - 5 pm CST. 1-866-986-7083

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252296salicylic acid 0.5 % Topical GelPSN3
252296salicylic acid 0.005 MG/MG Topical GelSCD3
252296salicylic acid 0.5 % Topical GelSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82691-140-00Acne Reparatif30 mL in 1 BOTTLE, PUMPGEL303
82691-140-00Acne Reparatif1 in 1 CARTONGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82691-140ACNE REPARATIF (SALICYLIC ACID) GEL [RV SKINCARE LLC]3Legacy NDC, 2 package rows20231108_d4d03ed9-8a24-4f53-b6ed-1ec0813e5bbe.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82691-14082691-140-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
OLIGOPEPTIDE-10Q46328TRNKIACT
NEPIDERMINTZK30RF92WIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PPG-26-BUTETH-262II1K6TZ4PIACT
SODIUM HYDROXIDE55X04QC32IIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PANTHENOLWV9CM0O67ZIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
SACCHAROMYCES LYSATER85W246Z1CIACT
GLYCERINPDC6A3C0OXIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
OATZ6J799EAJKIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PANTOLACTONE, (R)-J288D7O0JSIACT
LIMONENE, (+)-GFD7C86Q1WIACT
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
09891759-b1b0-6a81-e063-6394a90a2f89d4d03ed9-8a24-4f53-b6ed-1ec0813e5bbe2023-11-06WarningsExact identifier
spl id: 09891759-b1b0-6a81-e063-6394a90a2f89
spl set id: d4d03ed9-8a24-4f53-b6ed-1ec0813e5bbe

Reported adverse events (FAERS/openFDA)#

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