drug facts

drug facts
SPL v1
SPL
SPL Set ID a0c1e6b5-b0cb-4dea-abca-d1efbcacc40d
Route
topical
Published
Effective Date 2021-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (1 g)
Inactive Ingredients
water alcohol aloe vera leaf niacinamide zinc melaleuca alternifolia leaf glycerin arctium lappa root calendula officinalis flower smilax aristolochiifolia root citric acid monohydrate

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2021-06-30

Purpose

Acne Treatment

Description

Salicylic Acid 1%


Medication Information

Warnings

For external use only

Using other topical acne medications at the same time or immediately following use of this

product may increase dryness or irritation of the skin. If this occurs, only one medication should

be used unless directed by a doctor.

Uses

• for the treatment of acne

Purpose

Acne Treatment

Directions

• clean the skin thoroughly before applying this product • cover the entire

affected area with a thin layer one to three times daily • because excessive drying of the

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.

Inactive Ingredients

Water, Alcohol Deant., Aloe Barbadensis Leaf Juice, Niacinamide, Zinc PCA, Melaleuca Alternifolia Leaf Oil, Glycerin, Arctium Lappa Root Extract, Calendula Officinalis Flower Extract, Smilax Aristolochiaefolia Root Extrac, Citric Acid

Description

Salicylic Acid 1%

Principal Display Panel

Active Ingredients

Salicylic Acid 1%

Questions Or Comments?

Email us at [email protected] or call us toll-free 1-844-959-0666

Keep Out of Reach of Children

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


Structured Label Content

Warnings

For external use only

Using other topical acne medications at the same time or immediately following use of this

product may increase dryness or irritation of the skin. If this occurs, only one medication should

be used unless directed by a doctor.

Uses

• for the treatment of acne

Purpose

Acne Treatment

Directions

• clean the skin thoroughly before applying this product • cover the entire

affected area with a thin layer one to three times daily • because excessive drying of the

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.

Inactive Ingredients

Water, Alcohol Deant., Aloe Barbadensis Leaf Juice, Niacinamide, Zinc PCA, Melaleuca Alternifolia Leaf Oil, Glycerin, Arctium Lappa Root Extract, Calendula Officinalis Flower Extract, Smilax Aristolochiaefolia Root Extrac, Citric Acid

Principal Display Panel

Active Ingredients

Salicylic Acid 1%

Questions Or Comments? (Questions or comments?)

Email us at [email protected] or call us toll-free 1-844-959-0666

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)