SPL v6
SPL
SPL Set ID c5145f1d-78f7-22b4-e053-2a95a90a5c59
Route
TOPICAL
Published
Effective Date 2021-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.8 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-01

Description

Salicylic acid 1% ...........Acne Treatment


Medication Information

Warnings and Precautions

WARNINGS For external use only. Skin

irritation and dryness is more likely to

occur when using this product if you use

another topical acne medication at the

same time. If irritation occurs, only use

one topical acne medication at a time.

Indications and Usage

For the treatment of Acne

Dosage and Administration

DIRECTIONS Cleanse the skin. Use one pad to apply a

thin layer of solution to affected areas. Start with one

application daily, then increase to two times per day

(morning and evening). If dryness or peeling occurs,

reduce application to once a day or every other day.

Test on a small area of skin before applying to face. If

eye contact occurs, flush thoroughly with water.

Description

Salicylic acid 1% ...........Acne Treatment

Section 50565-1

Keep out of reach of children

Section 51727-6

INACTIVE INGREDIENTS Organic Aloe vera, organic

grain alcohol, cocamidopropyl dimethylamine, SE

Microbiome ComplexTM, sodium hydroxide, organic

lemon essential oil.

Section 51945-4

Section 55105-1

For the treatment of ACNE

Section 55106-9

Salicylic acid 1% ...........Acne Treatment


Structured Label Content

Indications and Usage (34067-9)

For the treatment of Acne

Dosage and Administration (34068-7)

DIRECTIONS Cleanse the skin. Use one pad to apply a

thin layer of solution to affected areas. Start with one

application daily, then increase to two times per day

(morning and evening). If dryness or peeling occurs,

reduce application to once a day or every other day.

Test on a small area of skin before applying to face. If

eye contact occurs, flush thoroughly with water.

Warnings and Precautions (34071-1)

WARNINGS For external use only. Skin

irritation and dryness is more likely to

occur when using this product if you use

another topical acne medication at the

same time. If irritation occurs, only use

one topical acne medication at a time.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS Organic Aloe vera, organic

grain alcohol, cocamidopropyl dimethylamine, SE

Microbiome ComplexTM, sodium hydroxide, organic

lemon essential oil.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For the treatment of ACNE

Section 55106-9 (55106-9)

Salicylic acid 1% ...........Acne Treatment


Advanced Ingredient Data


Raw Label Data

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