Gly-sal 10-2

Gly-sal 10-2
SPL v1
SPL
SPL Set ID 661cc58b-9360-4b96-b405-afdc2e378397
Route
TOPICAL
Published
Effective Date 2024-06-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Glycolic Acid Green Tea Leaf Cocamidopropyl Betaine Edetate Disodium Linoleamidopropyl Propylene Glycol-dimonium Chloride Phosphate Polysorbate 20 Water Fd&c Red No. 40 Sodium C12-15 Alketh-15 Sulfonate Sodium C14-16 Olefin Sulfonate Trolamine Fd&c Yellow No. 5 Zinc Pidolate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-06-10

Description

Drug Facts

Purpose

Acne medication


Medication Information

Purpose

Acne medication

Description

Drug Facts

Uses

For the treatment of acne of the body, with the skin enhancement properties of glycolic acid

Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children.
  • If swallowed, seek professional assistance or contact a Poison Control Center immediately.
  • Flammable; keep tightly closed, away from flame and heat.
  • Sunscreen use is recommended with any Glycolic Acid product and for an additional week thereafter, because some individuals may be more sensitive to sunlight.
Warnings
  • For external use only.
  • Direct spray away from face, especially eyes, lips and mouth.
  • If irritation develops, discontinue use and consult a doctor.
  • Using other topical acne medication 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.
Directions
  • Spray the entire affected area of the body one to three times daily.
  • Because excessive drying of the skin can occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Active Ingredient

Salicylic Acid 2%

Inactive Ingredients

Acetone, Ammonium Hydroxide, Disodium EDTA, Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Water, Imidazolidinyl Urea, Polysorbate-20, Purified Water, SD Alcohol 40B (13% v/v) Sodium Benzoate

Principal Display Panel 89 Ml Bottle Label

COMPLIMENTS OF

TOPIX

PHARMACEUTICALS, INC

Gly/Sal 10-2

Spray

Glycolic Acid 10%

Salicylic Acid USP, 2%

Net 3 fl. oz. (89 ml)

Available

Custom Branded

800.445.2595

[email protected]


Structured Label Content

Uses

For the treatment of acne of the body, with the skin enhancement properties of glycolic acid

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children.
  • If swallowed, seek professional assistance or contact a Poison Control Center immediately.
  • Flammable; keep tightly closed, away from flame and heat.
  • Sunscreen use is recommended with any Glycolic Acid product and for an additional week thereafter, because some individuals may be more sensitive to sunlight.
Purpose

Acne medication

Warnings
  • For external use only.
  • Direct spray away from face, especially eyes, lips and mouth.
  • If irritation develops, discontinue use and consult a doctor.
  • Using other topical acne medication 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.
Directions
  • Spray the entire affected area of the body one to three times daily.
  • Because excessive drying of the skin can occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Active Ingredient (Active ingredient)

Salicylic Acid 2%

Inactive Ingredients (Inactive ingredients)

Acetone, Ammonium Hydroxide, Disodium EDTA, Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Water, Imidazolidinyl Urea, Polysorbate-20, Purified Water, SD Alcohol 40B (13% v/v) Sodium Benzoate

Principal Display Panel 89 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 89 ml Bottle Label)

COMPLIMENTS OF

TOPIX

PHARMACEUTICALS, INC

Gly/Sal 10-2

Spray

Glycolic Acid 10%

Salicylic Acid USP, 2%

Net 3 fl. oz. (89 ml)

Available

Custom Branded

800.445.2595

[email protected]


Advanced Ingredient Data


Raw Label Data

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