FDA.reportPublic FDA data

PREP Everyday Clear Acne

Manufacturer
PREP Cosmetics LLC | Richard Hamer Associates LLC | Taka USA, Inc dba Cosmetic Innovations
Effective date
2018-10-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:48:38

Label at a glance#

ProductPREP Everyday Clear Acne
Active ingredientSALICYLIC ACID
Label structure10 sections

Dosage and administration

Clean the skin thoroughy before applying the product. Cover the entire affected area with a thin layer one to three times daily. 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 or peeling occurs, reduce application to once a day or every other day.

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 1%

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: Skin irritation or dryness is more likely to occur if you use another topicl acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • Rinse right away with water if it gets in the eyes.

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 thoroughy before applying the product.
  • Cover the entire affected area with a thin layer one to three times daily.
  • 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 or peeling occurs, reduce application to once a day or every other day.

Sensitivity Test for a New User

OTHER SAFETY INFORMATION

Apply product sparingly to one or two small affected areas during the first three days. If no discomfort occurs, follow the directions stated elsewhere on this label.

INACTIVE INGREDIENT SECTION

Azelaic Acid, Butylene Glycol, Chamaemelum Nobile Flower Oil, Ethylhexylglycerin, Geranium Maculatum Root Oil, Hydroxyethyl Cellulose, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxypropyl Distarch Phosphate, High Amylose Corn, Lavender Oil, Mandelic Acid, PEG-12 Glyceryl Dimyristate, PEG-23 Glyceryl Distearate, Phytate Sodium, Polysorbate 60, Potassium Sorbate, Propanediol, Rosa Canina Fruit, Salix Nigra Bark, Sorbitol, Squalane, Water

Other Information

STORAGE AND HANDLING SECTION

  • Store at room temperature

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton LabelCarton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70231-0017-12021-01-29C16284748780-1ba0f9c33-5651-a910-e053-dadaa90a0b85PREP Acne Treatment

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70231-001770231-0017-1

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
CHAMAEMELUM NOBILE FLOWER OILUB27587839IACT
PHYTATE SODIUM88496G1ERLIACT
GERANIUM MACULATUM ROOT OILH2E371EDYXIACT
POLYSORBATE 60CAL22UVI4MIACT
LAVENDER OILZBP1YXW0H8IACT
WATER059QF0KO0RIACT
PROPANEDIOL5965N8W85TIACT
PEG-12 GLYCERYL DIMYRISTATEVS4W16AQ3XIACT
SALIX NIGRA BARKQU52J3A5B3IACT
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN9F8ET54T05IACT
ROSA CANINA FRUIT3TNW8D08V3IACT
PEG-23 GLYCERYL DISTEARATE527412VE0UIACT
SORBITOL506T60A25RIACT
HYDROXYETHYL CELLULOSE (4000 CPS AT 1%)ZYD53NBL45IACT
SALICYLIC ACIDO414PZ4LPZACTIB
MANDELIC ACIDNH496X0UJXIACT
AZELAIC ACIDF2VW3D43YTIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
SQUALANEGW89575KF9IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
7871f3de-387b-7df3-e053-2a91aa0ad15626020825-0795-098e-e054-00144ff8d46c2018-10-17WarningsExact identifier
spl id: 7871f3de-387b-7df3-e053-2a91aa0ad156
spl set id: 26020825-0795-098e-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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