ACNE PRONE

Manufacturer
Biological Health Group Corporation | Deserving Health International Corp
Effective date
2023-05-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:30:14

Label at a glance#

ProductACNE PRONE
Active ingredientSALICYLIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

Active ingredient Purpose

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid – 1.50% Acne Medication

Purpose

OTC - PURPOSE SECTION

Acne medication

Use

INDICATIONS & USAGE SECTION

For the treatment of acne

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

​When using this product • 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. • Avoid contact with eyes; if contact occurs, rinse thoroughly with water. Avoid contact with eyes; if contact occurs, rinse thoroughly with water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions ​
• clean the skin thoroughly before applying this 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.
• May be applied under make-up.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Water, Aloe Vera,Vitamin A,Vitamin E, Tea Tree Essential Oil, Rose Hip Oil, Grapefruit Seed Extract.

Discontinue use if

OTC - STOP USE SECTION

Discontinue use if excessive skin irritation develops or increase. If irritation persists, consult a health care practitioner. Hypersensitivity, such as allergy, has been known to occur; in which case, discontinue use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 15mLLabel 15mL

Box 15mLBox 15mL

Label 50 mLLabel 50 mL

Box 50 mLBox 50 mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69711-003-032023-06-08C16284748780-19d75b9d0-45cd-f424-e053-dadaa90a57ceACNE PRONE
69711-003-042023-06-08C16284748780-19d75b9d0-45cd-f424-e053-dadaa90a57ceACNE PRONE
69711-003-032020-01-31C16284748780-19d75b9d0-45cd-f424-e053-dadaa90a57ceACNE PRONE
69711-003-042020-01-31C16284748780-19d75b9d0-45cd-f424-e053-dadaa90a57ceACNE PRONE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
CITRUS PARADISI SEEDINACTIVE INGREDIENT12F08874Y71
ROSA CANINA FRUIT OILINACTIVE INGREDIENTCR7307M3QZ1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G1
VITAMIN AINACTIVE INGREDIENT81G40H8B0T1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69711-00369711-003-04, 69711-003-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact identifier — unii candidate
10 equally ranked IID candidates

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
0cdad7b4-0d7b-6071-e063-6394a90a88d618d3a20f-d7cb-3449-e054-00144ff88e882023-12-19WarningsExact identifier
spl set id: 18d3a20f-d7cb-3449-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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