drug facts

drug facts
SPL v1
SPL
SPL Set ID 2ac3a8c0-e0ed-435f-90fb-72c7a55a0673
Route
topical
Published
Effective Date 2025-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (12 mg)
Inactive Ingredients
water azelaic acid c15-19 alkane glycerin triethyl citrate diglycerin panthenol silica ammonium polyacryloyldimethyl taurate taraxacum officinale root zinc gluconate glyceryl stearate peg-100 stearate sodium hyaluronate sodium hydroxide sodium phosphate disodium phosphate hydroxyethylcellulose tetrasodium glutamate diacetate citric acid trisodium ethylenediamine disuccinate pentylene glycol polysorbate 60

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-06-12

Purpose

Acne treatment

Description

Salicylic acid 1.2%


Medication Information

Warnings

For external use only

Uses
  • for the treatment of acne
  • clears acne blemishes
  • penetrates pores to control acne blemishes
  • helps prevent new acne blemishes from forming
Purpose

Acne treatment

Directions
  • shake well before use
  • 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
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Other Information
  • store at room temperature 68⁰ – 77⁰F
  • protect from freezing
Inactive Ingredients

water, azelaic acid, C15-19 alkane, glycerin, triethyl citrate, diglycerin, panthenol, silica, ammonium polyacryloyldimethyl taurate, taraxacum officinale (dandelion) rhizome/root extract, zinc gluconate, glyceryl stearate, PEG-100 stearate, sodium hyaluronate, sodium hydroxide, sodium phosphate, disodium phosphate, hydroxyethylcellulose, hydroxypropyl starch phosphate, tetrasodium glutamate diacetate, citric acid, trisodium ethylenediamine disuccinate, pentylene glycol, polysorbate 60, fragrance

Description

Salicylic acid 1.2%

Section 51945-4

Active Ingredient

Salicylic acid 1.2%

Questions Or Comments?

1-888-LRP LABO

1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

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

Warnings

For external use only

Uses
  • for the treatment of acne
  • clears acne blemishes
  • penetrates pores to control acne blemishes
  • helps prevent new acne blemishes from forming
Purpose

Acne treatment

Directions
  • shake well before use
  • 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
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Other Information (Other information)
  • store at room temperature 68⁰ – 77⁰F
  • protect from freezing
Inactive Ingredients (Inactive ingredients)

water, azelaic acid, C15-19 alkane, glycerin, triethyl citrate, diglycerin, panthenol, silica, ammonium polyacryloyldimethyl taurate, taraxacum officinale (dandelion) rhizome/root extract, zinc gluconate, glyceryl stearate, PEG-100 stearate, sodium hyaluronate, sodium hydroxide, sodium phosphate, disodium phosphate, hydroxyethylcellulose, hydroxypropyl starch phosphate, tetrasodium glutamate diacetate, citric acid, trisodium ethylenediamine disuccinate, pentylene glycol, polysorbate 60, fragrance

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

Salicylic acid 1.2%

Questions Or Comments? (Questions or comments?)

1-888-LRP LABO

1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

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

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