Walgreens Acne Spot Treatment: Package Insert and Label Information

WALGREENS ACNE SPOT TREATMENT- salicylic acid gel
WALGREEN COMPANY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

Salicylic acid 2.0%

Purpose

Acne Medication

Uses

• For the treatment of acne

Warnings

For external use only

FLAMMABLE: Keep away from spark, heat, or flame.

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, fluch thoroughly with water.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Directions

• Cleanse skin thoroughly before applying product.
• Cover the entire afffected 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

May stain some fabrics

Inactive ingredients

water, alcohol denat, hamamelis virginiana (witch hazel) extract, polyacrylamide, C13-14 isoparaffin, glycerin, cyclopentasiloxane, C12-15 alkyl lactate, laureth-7, phenoxyethanol, cetyl lactate, PPG-2 isoceteth-20 acetate, cocamidopropyl PG-dimonium chloride phosphate, polysorbate 20, phenethyl dimethicone, fragrance, dehydroxanthan gum, hexylene glycol, ammonium hydroxide, tetrasodium EDTA, butylene glycol, capryloyl glycine, sarcosine, cinnamomum zeylanicum bark extract, cedrus atlantica bark extract, portulaca oleracea extract

WALGREENS ACNE SPOT TREATMENT salicylic acid gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0983 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 20 mg in 1 mL

Inactive Ingredients Ingredient Name Strength C12-15 ALKYL LACTATE C13-14 ISOPARAFFIN CAPRYLOYL GLYCINE CEDRUS ATLANTICA BARK COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE DEHYDROXANTHAN GUM DIMETHICONE AMMONIA CETYL LACTATE GLYCERIN POLYSORBATE 20 SARCOSINE EDETATE SODIUM (EDETIC ACID) CYCLOMETHICONE 5 HAMAMELIS VIRGINIANA LEAF POLYACRYLAMIDE (1500 MW) LAURETH-7 ALCOHOL CINNAMON BARK OIL PURSLANE PPG-2 ISOCETETH-20 ACETATE WATER BUTYLENE GLYCOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0363-0983-52 1 TUBE in 1 CARTON contains a TUBE (0363-0983-51) 1 NDC:0363-0983-51 22.1 mL in 1 TUBE This package is contained within the CARTON (0363-0983-52)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/06/2020

Labeler — WALGREEN COMPANY (008965063)

Revised: 01/2022 WALGREEN COMPANY