SPL v4
SPL
SPL Set ID 0897ccca-fa18-873f-e063-6394a90a59ab
Route
TOPICAL
Published
Effective Date 2023-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.5 g)
Inactive Ingredients
Sodium Phosphate Sodium Methyl Cocoyl Taurate Sodium Chloride Ethylene Glycol Monobenzyl Ether Asiaticoside Madecassoside Citric Acid Monohydrate Potassium Hydroxide Palmitic Acid Gluconolactone Lauric Acid Peppermint Oil Myristic Acid 1,2-hexanediol Centella Asiatica Triterpenoids Melaleuca Alternifolia (tea Tree) Leaf Oil Glycyrrhizinate Dipotassium Glycerin Butylene Glycol Lauryl Betaine Coco-betaine Water Glyceryl Monostearate Ethylhexylglycerin Madecassic Acid Ethohexadiol Asiatic Acid Hydroxyethyl Cellulose, Unspecified Sodium Phosphate, Dibasic, Anhydrous

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-05

Description

Salicylic Acid 0.5%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

■ For the treatment of acne

■ Clears acne pimples

■ Helps prevent new acne pimples from forming.

Dosage and Administration

DOSAGE & ADMINISTRATION

Description

Salicylic Acid 0.5%

Section 50565-1

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

Section 50567-7

When using this productskin irritation and dryness is more likely to occur if you use another topcial acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Section 51727-6

Water, Myristic Acid, Glycerin, Potassium Hydroxide, Lauric Acid, Palmitic acid, Butylene Glycol, Stearic Acid, Sodium Methyl Cocoyl Taurate, Lauryl Betaine, Benzyl Glycol, Cetearyl Glucoside, Sorbitan Olivate, Sodium Chloride, Coco-Betaine, Glyceryl Stearate, 1,2-Hexanediol, Centella Asiatica Extract, Ethylhexylglycerin, Asiaticoside, Madecassic Acid, Asiatic Acid, Melaleuca Alternifolia (Tea Tree] Leaf Water, Mentha Piperita [Peppermint] Oil, Cetearyl Alcohol, Ethyl Hexanediol, Dipotassium Glycyrrhizate, Madecassoside, Gluconolactone, Citric acid, Artemisia Vulgaris Extract, Calamine

Section 51945-4

Section 55105-1

Acne treatment

Section 55106-9

Salicylic Acid 0.5%

Section 59845-8

■Clean the skin thoroughly before applying this product.

■Take an appropriate amount and foam enough on your face then wash off with water.

■Because excessive drying of the skin may occur, start with one application daily, then gradually increase if needed or as directed by a doctor.

■If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

■ Avoid using BHA-containing products on infants and children.

Section 60561-8

Other Information

■ Sunburn Alert: This product contains an alpha hydroxy acid [AHA] that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

■ Test any product that contains a BHA on a small area of skin before applying it to a large area. If you use cosmetics with BHAS and experience skin irritation or prolonged stinging, stop using the product and consult your physician.


Structured Label Content

Indications and Usage (34067-9)

■ For the treatment of acne

■ Clears acne pimples

■ Helps prevent new acne pimples from forming.

Dosage and Administration (34068-7)

DOSAGE & ADMINISTRATION

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this productskin irritation and dryness is more likely to occur if you use another topcial acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Section 51727-6 (51727-6)

Water, Myristic Acid, Glycerin, Potassium Hydroxide, Lauric Acid, Palmitic acid, Butylene Glycol, Stearic Acid, Sodium Methyl Cocoyl Taurate, Lauryl Betaine, Benzyl Glycol, Cetearyl Glucoside, Sorbitan Olivate, Sodium Chloride, Coco-Betaine, Glyceryl Stearate, 1,2-Hexanediol, Centella Asiatica Extract, Ethylhexylglycerin, Asiaticoside, Madecassic Acid, Asiatic Acid, Melaleuca Alternifolia (Tea Tree] Leaf Water, Mentha Piperita [Peppermint] Oil, Cetearyl Alcohol, Ethyl Hexanediol, Dipotassium Glycyrrhizate, Madecassoside, Gluconolactone, Citric acid, Artemisia Vulgaris Extract, Calamine

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Acne treatment

Section 55106-9 (55106-9)

Salicylic Acid 0.5%

Section 59845-8 (59845-8)

■Clean the skin thoroughly before applying this product.

■Take an appropriate amount and foam enough on your face then wash off with water.

■Because excessive drying of the skin may occur, start with one application daily, then gradually increase if needed or as directed by a doctor.

■If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

■ Avoid using BHA-containing products on infants and children.

Section 60561-8 (60561-8)

Other Information

■ Sunburn Alert: This product contains an alpha hydroxy acid [AHA] that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

■ Test any product that contains a BHA on a small area of skin before applying it to a large area. If you use cosmetics with BHAS and experience skin irritation or prolonged stinging, stop using the product and consult your physician.


Advanced Ingredient Data


Raw Label Data

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