Drug Fact

Drug Fact
SPL v5
SPL
SPL Set ID 6ab34d5e-4439-4c64-ad0d-6c8641109c38
Route
TOPICAL
Published
Effective Date 2015-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1 g)
Inactive Ingredients
Polyacrylamide (10000 Mw) Water Alcohol Camphor Oil C13-14 Isoparaffin Laureth-7 Sodium Benzoate Camellia Sinensis Whole Phenoxyethanol Butylene Glycol Ethylhexylglycerin Tea Tree Oil Aloe Vera Leaf Witch Hazel

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-10-20

Description

Active Ingredient: Salicylic Acid 1.0 %


Medication Information

Warnings and Precautions

Warning:

For external use only

Indications and Usage

Uses:

For the treatment of acne

Helps prevent new acne blemishes

Dosage and Administration

Directions:

Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of skin may occur, start with one application daily, then gradually increase to two or three times daily if needed 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: Salicylic Acid 1.0 %

Section 44425-7

Other Information:

Protect the product in this container from exessive heat and direct sun

Section 50565-1

Keep Out of Reach of Children

Section 50567-7

When Using This Product:

Keep out of eyes, rinse with water to remove.

Skin irrittion and dryness is more likely to occur if you use another topical acne medications at the same time.  If irritation occurs, only use one medication at a time.

Section 50569-3

Stop use and ask a doctor If

rash occurs

Section 51727-6

Inactive Ingredient:

Water,  Alcohol Denat, Hamamelis Birginiana (Witch Hazel), Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Cinnamomum Camphora (Camphor) Bark oil, Sodium Benzoate, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Camellia Sinensis Leaf Extract, Butylene Glycol, Aloe Barbadensis Leaf Extract, Phenoxyethanol, Ethylhexylglycerin

Section 51945-4

Section 55105-1

Purpose:

Acne Treatment

Section 55106-9

Active Ingredient:

Salicylic Acid 1.0 %


Structured Label Content

Indications and Usage (34067-9)

Uses:

For the treatment of acne

Helps prevent new acne blemishes

Dosage and Administration (34068-7)

Directions:

Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of skin may occur, start with one application daily, then gradually increase to two or three times daily if needed 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 44425-7 (44425-7)

Other Information:

Protect the product in this container from exessive heat and direct sun

Section 50565-1 (50565-1)

Keep Out of Reach of Children

Section 50567-7 (50567-7)

When Using This Product:

Keep out of eyes, rinse with water to remove.

Skin irrittion and dryness is more likely to occur if you use another topical acne medications at the same time.  If irritation occurs, only use one medication at a time.

Section 50569-3 (50569-3)

Stop use and ask a doctor If

rash occurs

Section 51727-6 (51727-6)

Inactive Ingredient:

Water,  Alcohol Denat, Hamamelis Birginiana (Witch Hazel), Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Cinnamomum Camphora (Camphor) Bark oil, Sodium Benzoate, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Camellia Sinensis Leaf Extract, Butylene Glycol, Aloe Barbadensis Leaf Extract, Phenoxyethanol, Ethylhexylglycerin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:

Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient:

Salicylic Acid 1.0 %


Advanced Ingredient Data


Raw Label Data

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