Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 230d173f-92c1-2e98-e063-6394a90acb21
Route
TOPICAL
Published
Effective Date 2024-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.5 g)
Inactive Ingredients
Water Niacinamide Polydextrose Magnesium Sulfate, Unspecified Phenoxyethanol Bacteriophage Phi X174 Glycerin Sodium Chloride Betasizofiran Caffeine Butylene Glycol Hydroxyethyl Cellulose, Unspecified Sodium Phosphate Calcium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-26

Description

Active ingredient : Encapsulated Salicylic Acid 0.5%


Medication Information

Warnings and Precautions

Warning: For external use only

Indications and Usage

Uses:

For the treatment of acne

Help clear up acne blemishes and allows skin to heal

Dosage and Administration

Direction:

Clean the skin thoroughly before applying product

Cover the entire affected area with the thin layer one to three time daily

Because excessive drying of the skin may ocure, start with one application daily, then gradually increases to two three time daily or as directed by a doctor

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

Description

Active ingredient : Encapsulated Salicylic Acid 0.5%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

If irritation occurs

Section 50567-7

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

Section 50570-1

If you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time

Section 51727-6

Inactive ingredient: Water, Glycerin, Butylene Glycol, Hydroxyethylcellulose, C.Acnes Bacteriophage, Sodium Phosphate, Sodium Chloride, Phenoxyethanol, Polydextrose, Sclerotium Gum, Niacinamide, Magnesium Sulfate, Caffeine, Calcium Chloride

Section 51945-4

Section 55105-1

Purpose: Acen Treatment

Section 55106-9

Active ingredient : Encapsulated Salicylic Acid 0.5%

Section 60561-8

Other information:

Store at room temperatures

Avoid high temperature

Protect from freezing

Keep away from flame, fire and heat


Structured Label Content

Indications and Usage (34067-9)

Uses:

For the treatment of acne

Help clear up acne blemishes and allows skin to heal

Dosage and Administration (34068-7)

Direction:

Clean the skin thoroughly before applying product

Cover the entire affected area with the thin layer one to three time daily

Because excessive drying of the skin may ocure, start with one application daily, then gradually increases to two three time daily or as directed by a doctor

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

Warnings and Precautions (34071-1)

Warning: For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

If irritation occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

If you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time

Section 51727-6 (51727-6)

Inactive ingredient: Water, Glycerin, Butylene Glycol, Hydroxyethylcellulose, C.Acnes Bacteriophage, Sodium Phosphate, Sodium Chloride, Phenoxyethanol, Polydextrose, Sclerotium Gum, Niacinamide, Magnesium Sulfate, Caffeine, Calcium Chloride

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Acen Treatment

Section 55106-9 (55106-9)

Active ingredient : Encapsulated Salicylic Acid 0.5%

Section 60561-8 (60561-8)

Other information:

Store at room temperatures

Avoid high temperature

Protect from freezing

Keep away from flame, fire and heat


Advanced Ingredient Data


Raw Label Data

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