SPL v7
SPL
SPL Set ID a61d0f78-9759-4085-b5e5-577d349be9fd
Route
TOPICAL
Published
Effective Date 2018-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.3 g)
Inactive Ingredients
Water Dimethicone Isododecane Hexyldecanol Glycolic Acid Squalane Levomenol Butylene Glycol Palmitamide Ethylhexylglycerin Rapeseed Sterol Laureth-12 Polysorbate 60 Decyl Glucoside Lauryl Glucoside Stearic Acid Sodium Hydroxide Edetate Disodium Caprylyl Glycol Hexylene Glycol Phenoxyethanol O-cymen-5-ol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-04-01

Description

Drug Facts

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50568-5

Ask a doctor or pharmacist before using if you are using other topical acne medications at he same time or immediately following use of this product. this may increase dryness or irritation of the skin. if this occurs, only one medication should be used unless directed by a doctor.

Warnings

For external use only

Directions
  • cleanse skin thoroughly before applying medication. cover the entire affected area with a thin layer 1-3 times daily
  • because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2-3 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.
Indications
  • for the treatment of acne
Active Ingredient

Salicylic Acid (2.0%)

Inactive Ingredients

water, dimethicone, isododecane, polysilicone-11, alcohol denat., hexyldecanol, glycolic acid, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, coco-caprylate/caprate, squalane, bisabolol, butylene glycol, cetylhydroxyproline palmitamide, ethylhexylglycerin, lecithin, oligopeptide-10, trimethylpentanediol/ adipic acid copolymer, rassica campestris (rapeseed) sterols, laureth-12, polysorbate 60, decyl glucoside, lauryl glucoside, stearic acid, sodium acrylates copolymer, ethoxydiglycol, sodium hydroxide, disodium edta, aprylyl glycol, hexylene glycol, phenoxyethanol, o-cymen-5-ol.

Questions Or Comments?

Call toll-free 1-800-568-3151 from 8a.m. - 5p.m. MST

(Monday - Friday)

When Using This Product
  • avoid contact with eyes. If contact occurs, flush thoroughly with water. If redness or irritation persists, contact your doctor right away.
Keep Out of Reach of Children.
  • If swallowed, get medical help or contact a Poison Control Center right away.
Principal Display Panel 15 Ml Box Label

clear

days ahead™

philosophy ®: a blemish

is “small stuff” and not

worth the worry time.

family, friends and your

health are the “big stuff”

that really matter. Instead

of focusing on what is

wrong, focus on what is

right and watch your days

become clearer.

fast-acting salicylic acid

acne spot treatment

15 ml/0.5 fl. oz.

Principal Display Panel 15 Ml Bottle Label

clear

days ahead™

philosophy ®: instead

of focusing on what is

wrong, focus on what

is right and watch your

days become clearer

fast-acting salicylic acid

acne spot treatment

15 ml/0.5 fl oz.


Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before using if you are using other topical acne medications at he same time or immediately following use of this product. this may increase dryness or irritation of the skin. if this occurs, only one medication should be used unless directed by a doctor.

Purpose

Acne Treatment

Warnings

For external use only

Directions
  • cleanse skin thoroughly before applying medication. cover the entire affected area with a thin layer 1-3 times daily
  • because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2-3 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.
Indications
  • for the treatment of acne
Active Ingredient (Active ingredient)

Salicylic Acid (2.0%)

Inactive Ingredients (Inactive ingredients)

water, dimethicone, isododecane, polysilicone-11, alcohol denat., hexyldecanol, glycolic acid, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, coco-caprylate/caprate, squalane, bisabolol, butylene glycol, cetylhydroxyproline palmitamide, ethylhexylglycerin, lecithin, oligopeptide-10, trimethylpentanediol/ adipic acid copolymer, rassica campestris (rapeseed) sterols, laureth-12, polysorbate 60, decyl glucoside, lauryl glucoside, stearic acid, sodium acrylates copolymer, ethoxydiglycol, sodium hydroxide, disodium edta, aprylyl glycol, hexylene glycol, phenoxyethanol, o-cymen-5-ol.

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-568-3151 from 8a.m. - 5p.m. MST

(Monday - Friday)

When Using This Product (When using this product)
  • avoid contact with eyes. If contact occurs, flush thoroughly with water. If redness or irritation persists, contact your doctor right away.
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.
Principal Display Panel 15 Ml Box Label (Principal Display Panel - 15 ml Box Label)

clear

days ahead™

philosophy ®: a blemish

is “small stuff” and not

worth the worry time.

family, friends and your

health are the “big stuff”

that really matter. Instead

of focusing on what is

wrong, focus on what is

right and watch your days

become clearer.

fast-acting salicylic acid

acne spot treatment

15 ml/0.5 fl. oz.

Principal Display Panel 15 Ml Bottle Label (Principal Display Panel - 15 ml Bottle Label)

clear

days ahead™

philosophy ®: instead

of focusing on what is

wrong, focus on what

is right and watch your

days become clearer

fast-acting salicylic acid

acne spot treatment

15 ml/0.5 fl oz.


Advanced Ingredient Data


Raw Label Data

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