Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0fc55cdd-a76f-4acc-8449-81e9eff2a3f9
Route
TOPICAL
Published
Effective Date 2014-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Glycerin Myristic Acid Stearic Acid Sodium Lauroyl Sarcosinate Palmitic Acid Potassium Hydroxide Lauric Acid Polyquaternium-10 (400 Cps At 2%) Edetate Sodium Pentasodium Pentetate Etidronate Tetrasodium Menthol Aloe Vera Leaf Maltodextrin Potassium Sorbate Sodium Benzoate Phenoxyethanol Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-09-22

Description

SALICYLIC ACID 2%

Purpose

ACNE TREATMENT


Medication Information

Purpose

ACNE TREATMENT

Description

SALICYLIC ACID 2%

Uses

FOR THE TREATMENT OF ACNE

Section 50566-9

IRRITATION OR REDNESS DEVELOPS AND LASTS

Warnings

FOR EXTERNAL USE ONLY

Directions

USE TWICE A DAY. WET FACE AND NECK. APPLY TO HANDS WITH SOME WATER AND WORK INTO LATHER. GENTLY MASSAGE FACE AND NECK. RINSE THOROUGHLY

Label Copy

Active Ingredient

SALICYLIC ACID 2%

Other Information

STORE BETWEEN 20°C - 25°C (68°F - 77°F)

Inactive Ingredients

WATER, GLYCEIRN, MYRISTIC ACID, STEARIC ACID, SODIUM LAUROYL SARCOSINATE, PALMITIC ACID, POTASSIUM HYDROXIDE, LAURIC ACID, POLYQUATERNIUM-10, FRAGRANCE, TETRASODIUM EDTA, PENTASODIUM PENTETATE, TETRASODIUM ETIDRONATE, MENTHOL, ALOE BARBADENSIS LEAF JUICE, MALTODEXTRIN, POTASSIUM SORBATE, SODIUM BENZOATE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN

Questions Or Comments?

1-800-632-6900

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222

Ask Doctor Or Pharmacist Before Use If You Are

USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS OTHERWISE DIRECTED BY A DOCTOR


Structured Label Content

Uses (USES)

FOR THE TREATMENT OF ACNE

Section 50566-9 (50566-9)

IRRITATION OR REDNESS DEVELOPS AND LASTS

Purpose (PURPOSE)

ACNE TREATMENT

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Directions (DIRECTIONS)

USE TWICE A DAY. WET FACE AND NECK. APPLY TO HANDS WITH SOME WATER AND WORK INTO LATHER. GENTLY MASSAGE FACE AND NECK. RINSE THOROUGHLY

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

SALICYLIC ACID 2%

Other Information (OTHER INFORMATION)

STORE BETWEEN 20°C - 25°C (68°F - 77°F)

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, GLYCEIRN, MYRISTIC ACID, STEARIC ACID, SODIUM LAUROYL SARCOSINATE, PALMITIC ACID, POTASSIUM HYDROXIDE, LAURIC ACID, POLYQUATERNIUM-10, FRAGRANCE, TETRASODIUM EDTA, PENTASODIUM PENTETATE, TETRASODIUM ETIDRONATE, MENTHOL, ALOE BARBADENSIS LEAF JUICE, MALTODEXTRIN, POTASSIUM SORBATE, SODIUM BENZOATE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-800-632-6900

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222

Ask Doctor Or Pharmacist Before Use If You Are (ASK DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE)

USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS OTHERWISE DIRECTED BY A DOCTOR


Advanced Ingredient Data


Raw Label Data

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