Acne Fighting Spot Gel

Acne Fighting Spot Gel
SPL v6
SPL
SPL Set ID eca08910-58b9-4ce6-8e97-4b97c30784f5
Route
TOPICAL
Published
Effective Date 2024-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 mg)
Inactive Ingredients
Sodium Benzoate Phenoxyethanol Denatonium Benzoate Water Alcohol Butylene Glycol Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Sodium Hydroxide Tea Tree Oil Hamamelis Virginiana Top Aloe Vera Leaf Green Tea Leaf Tert-butyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-25

Description

Salicylic Acid 1%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Salicylic Acid 1%

Uses
  • For the treatment of acne
  • Helps prevent new acne blemishes
Warnings

For external use only.

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 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. Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated eleswhere on this label.

Drug Facts

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Salicylic Acid 1%

Inactive Ingredients

Water (Aqua), Alcohol Denat., Butylene Glycol, Polyacrylate Crosspolymer-6, Camphor, Sodium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Hamamelis Virginiana (Witch Hazel) Extract, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, T-Butyl Alcohol, Sodium Benzoate, Phenoxyethanol, Denatonium Benzoate

Questions Or Comments

1-888-315-9814

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.

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 treatment of acne
  • Helps prevent new acne blemishes
Purpose

Acne Treatment

Warnings

For external use only.

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 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. Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated eleswhere on this label.

Drug Facts

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

Active Ingredients (Active ingredients)

Salicylic Acid 1%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Alcohol Denat., Butylene Glycol, Polyacrylate Crosspolymer-6, Camphor, Sodium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Hamamelis Virginiana (Witch Hazel) Extract, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, T-Butyl Alcohol, Sodium Benzoate, Phenoxyethanol, Denatonium Benzoate

Questions Or Comments (Questions or comments)

1-888-315-9814

When Using This Product (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.

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)