SPL v2
SPL
SPL Set ID 6b4faec1-fded-546a-e053-2991aa0a44bd
Route
TOPICAL
Published
Effective Date 2018-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.025 g) Camphor (synthetic) (0.02 g) Menthol (0.05 g)
Inactive Ingredients
Glycol Stearate Se Edetate Disodium Acetylated Lanolin Potassium Hydroxide Polysorbate 80 Water Stearic Acid Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-08-01


Medication Information

Indications and Usage

Purpose

Dosage and Administration

Uses

Storage

Warnings

Directions

Do Not Use

Active Ingredients

Inactive Ingredients

Ask A Doctor Before Use

When Using This Product

Stop Use and Ask A Doctor If

Keep Out of Reach of Children to Avoid Accidental Ingestion


Structured Label Content

Uses (USES)

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Purpose (PURPOSE)

Storage (STORAGE)

Warnings (WARNINGS)

Directions (DIRECTIONS)

Do Not Use (DO NOT USE)

Active Ingredients (ACTIVE INGREDIENTS)

Inactive Ingredients (INACTIVE INGREDIENTS)

Ask A Doctor Before Use (ASK A DOCTOR BEFORE USE)

When Using This Product (WHEN USING THIS PRODUCT)

Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

Keep Out of Reach of Children to Avoid Accidental Ingestion (KEEP OUT OF REACH OF CHILDREN TO AVOID ACCIDENTAL INGESTION)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)