Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 83aaa7f8-cf5b-1faa-e053-2a91aa0a98cd
Route
TOPICAL
Published
Effective Date 2019-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Water Alcohol Butylene Glycol Hamamelis Virginiana Leaf Water Lactic Acid Urea Sodium Hydride Phenoxyethanol Allantoin Menthyl Lactate, (-)- Rosa Canina Fruit Benzyl Benzoate Citronellal Geranial Cyclohexyl Cinnamate Linalool, (+)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-03-09

Description

Salicylic Acid 0.5%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Salicylic Acid 0.5%

Uses

• for the management of acne

• reduces the severity of oiliness and smooths complexion

• helps prevent the development of new acne blemishes

Warnings

For external use only

When using this product

• avoid contact with the eyes

• if contact occurs, rinse thoroughly with water

• using other topical acne medications at the same time or immediately following use of this product may increase dyness or irriation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

• if you develop severe irritation, burning, or itching of the skin

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.

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

Other Information
  • store at 20-25C (68-77F)
Active Ingredients

Salicylic Acid 0.5%

Inactive Ingredients

Aqua/Water/Eau, SD Alcohol 40-B (Alcohol Denat.), Butylene Glycol, Hamamelis Virginiana (Witch Hazel) Water, Lactic Acid, Urea, Sodium PCA, Sodium Hydroxide, Phenoxyethanol, Alcohol, Allantoin, Menthyl Lactate, Rosa Canina Fruit Extract, Parfum/Fragrance, Benzyl Benzoate, Citronellol, Geraniol, Hexyl Cinnamal, Linalool

Questions Or Comments?

1-833-251-0388

Principal Display Panel

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

Uses

• for the management of acne

• reduces the severity of oiliness and smooths complexion

• helps prevent the development of new acne blemishes

Purpose

Acne Treatment

Warnings

For external use only

When using this product

• avoid contact with the eyes

• if contact occurs, rinse thoroughly with water

• using other topical acne medications at the same time or immediately following use of this product may increase dyness or irriation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

• if you develop severe irritation, burning, or itching of the skin

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.

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

Other Information
  • store at 20-25C (68-77F)
Active Ingredients

Salicylic Acid 0.5%

Inactive Ingredients

Aqua/Water/Eau, SD Alcohol 40-B (Alcohol Denat.), Butylene Glycol, Hamamelis Virginiana (Witch Hazel) Water, Lactic Acid, Urea, Sodium PCA, Sodium Hydroxide, Phenoxyethanol, Alcohol, Allantoin, Menthyl Lactate, Rosa Canina Fruit Extract, Parfum/Fragrance, Benzyl Benzoate, Citronellol, Geraniol, Hexyl Cinnamal, Linalool

Questions Or Comments? (Questions or comments?)

1-833-251-0388

Principal Display Panel

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

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