SPL v2
SPL
SPL Set ID 1bf92da8-35bf-5f32-e063-6294a90a71cf
Route
TOPICAL
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.01 g)
Inactive Ingredients
Cetostearyl Alcohol Glycolic Acid Gluconolactone Acetyltributyl Citrate Alcohol Glycerin Coco-caprylate/caprate Cetearyl Glucoside Laponite Sodium Benzoate Water Medium-chain Triglycerides Dicaprylyl Ether Sodium Hydroxide Glucosamine Hydrochloride Xanthan Gum Glyceryl Monostearate Phenyl-n-tert-butylnitrone Hamamelis Virginiana Top Water Saccharum Officinarum Stem Fructooligosaccharides Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-01

Description

Active Ingredients Salicylic Acid 1%

Purpose

Purpose Acne Treatment


Medication Information

Purpose

Purpose

Acne Treatment

Description

Active Ingredients Salicylic Acid 1%

Uses

Uses

  • For the treatment of acne.
  • Dries and clears acne blemishes and allows skin to heal.
  • Penetrates pores to reduce the number of acne blemishes, blackheads, and whiteheads.
  • Helps prevent the development of new acne blemishes, blackheads, and whiteheads.
Section 51945-4

Warnings

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.

Stop use and ask a doctor if rash occurs.

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

Control Center right away.

Directions

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 skin care professional · If bothersome dryness or

peeling occurs, reduce application to once a day or every other day

Active Ingredients

Active Ingredients

Salicylic Acid 1%

Inactive Ingredients

Inactive Ingredients: Aqua (Water), Glycerin, Caprylic/Capric Triglyceride, Glycolic Acid, Coco-Caprylate/Caprate, Cetearyl Alcohol, Cetearyl Glucoside, Glyceryl Stearate, Dicaprylyl Ether, Gluconolactone, Hamamelis Virginiana (Witch Hazel) Water, Fructooligosaccharides (D-beta), Phenyl t-Butylnitrone (Spin Trap), Alcohol, Xanthan Gum, Sodium Benzoate, Lithium Magnesium Sodium Silicate, Acetyl Tributyl Citrate, Glucosamine HCl (D), Citric Acid, Sodium Hydroxide

Questions Or Comments?

Questions or comments?

Skin Script™

Chandler, AZ 85226

www.skinscript.com

Keep Out of Reach of Children

Keep out of reach of children.


Structured Label Content

Uses

Uses

  • For the treatment of acne.
  • Dries and clears acne blemishes and allows skin to heal.
  • Penetrates pores to reduce the number of acne blemishes, blackheads, and whiteheads.
  • Helps prevent the development of new acne blemishes, blackheads, and whiteheads.
Section 51945-4 (51945-4)

Purpose

Purpose

Acne Treatment

Warnings

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.

Stop use and ask a doctor if rash occurs.

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

Control Center right away.

Directions

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 skin care professional · If bothersome dryness or

peeling occurs, reduce application to once a day or every other day

Active Ingredients

Active Ingredients

Salicylic Acid 1%

Inactive Ingredients

Inactive Ingredients: Aqua (Water), Glycerin, Caprylic/Capric Triglyceride, Glycolic Acid, Coco-Caprylate/Caprate, Cetearyl Alcohol, Cetearyl Glucoside, Glyceryl Stearate, Dicaprylyl Ether, Gluconolactone, Hamamelis Virginiana (Witch Hazel) Water, Fructooligosaccharides (D-beta), Phenyl t-Butylnitrone (Spin Trap), Alcohol, Xanthan Gum, Sodium Benzoate, Lithium Magnesium Sodium Silicate, Acetyl Tributyl Citrate, Glucosamine HCl (D), Citric Acid, Sodium Hydroxide

Questions Or Comments? (Questions or comments?)

Questions or comments?

Skin Script™

Chandler, AZ 85226

www.skinscript.com

Keep Out of Reach of Children

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)