1a9a4a8e-853a-d7f0-e063-6394a90acfac

SPL v2
SPL
SPL Set ID 1a9a4a8e-853a-d7f0-e063-6394a90acfac
Route
topical
Published
Effective Date 2024-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (0.5 g)
Inactive Ingredients
water pentylene glycol propanediol glycereth-26 tromethamine edetate disodium mentha x rotundifolia leaf madecassic acid madecassoside butylene glycol 1,2-hexanediol lactobionic acid mentha spicata asiaticoside panthenol ethoxydiglycol capryloyl salicylic acid asiatic acid centella asiatica triterpenoids houttuynia cordata flowering top succinic acid ectoine mandelic acid

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
otc monograph drug active Since 2024-12-01

Purpose

Acne Treatment

Description

Salicylic Acid 0.5%


Medication Information

Warnings

For external use only. 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.
  • Avoid contact with eyes. If contact occurs, flush thoroughly with water.
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.
Other Information

Store at room temperature

Inactive Ingredients

Water(Aqua/Eau), Propanediol, Pentylene Glycol, Glycereth-26, Tromethamine, Ethoxydiglycol, Succinic Acid, Panthenol, Lactobacillus Ferment, Disodium EDTA, Butylene Glycol, Ectoin, 1,2-Hexanediol, LactobionicAcid, MandelicAcid, Capryloyl Salicylic Acid, Centella Asiatica Extract, Houttuynia Cordata Extract, Mentha Aquatica Extract, Mentha Rotundifolia Leaf Extract, Mentha Viridis (Spearmint)

Extract, Asiatic Acid, Asiaticoside, Madecassic Acid, Madecassoside

Description

Salicylic Acid 0.5%

Use

For the treatment of acne.

Package Label

Active Ingredient

Salicylic Acid 0.5%

Questions Or Comments?

Contact to www.dr-g.com

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. 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.
  • Avoid contact with eyes. If contact occurs, flush thoroughly with water.
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.
Other Information

Store at room temperature

Inactive Ingredients

Water(Aqua/Eau), Propanediol, Pentylene Glycol, Glycereth-26, Tromethamine, Ethoxydiglycol, Succinic Acid, Panthenol, Lactobacillus Ferment, Disodium EDTA, Butylene Glycol, Ectoin, 1,2-Hexanediol, LactobionicAcid, MandelicAcid, Capryloyl Salicylic Acid, Centella Asiatica Extract, Houttuynia Cordata Extract, Mentha Aquatica Extract, Mentha Rotundifolia Leaf Extract, Mentha Viridis (Spearmint)

Extract, Asiatic Acid, Asiaticoside, Madecassic Acid, Madecassoside

Use

For the treatment of acne.

Package Label (PACKAGE LABEL)

Active Ingredient (Active ingredient)

Salicylic Acid 0.5%

Questions Or Comments? (Questions or comments?)

Contact to www.dr-g.com

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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