SPL v6
SPL
SPL Set ID d7895387-100c-4cc4-9c25-0f3b9d0f5937
Route
TOPICAL
Published
Effective Date 2018-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.6 g)
Inactive Ingredients
Water Dimethicone Medium-chain Triglycerides Squalane .alpha.-tocopherol Acetate Octyldodecyl Neopentanoate Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Polysorbate 60 Diethylene Glycol Monoethyl Ether Sodium Hydroxide Edetate Disodium 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 the 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 (1.0%)

Inactive Ingredients

water, dimethicone, polysilicone-11, butylene glycol, acacia decurrens/jojoba/sunflower seed wax/polyglyceryl-3 esters, caprylic/capric triglyceride, sodium acrylates copolymer, squalane, lecithin, oligopeptide- 10, tocopheryl acetate, trimethylpentanediol/adipic acid copolymer, octyldodecyl neopentanoate, ceteareth-20, cetearyl alcohol, polysorbate 60, ppg-12/smdi copolymer, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, ethoxydiglycol, sodium hydroxide, disodium edta, 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.
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel 60 Ml Box Label

clear

days ahead

philosophy ®: total clarity is

when your head and your

heart come together wanting

and needing the exact

same things. opposition and

uncertainty disappear, and

perfect balance is restored.

oil-free salicylic acid

acne treatment & moisturizer

60 ml/2 fl. oz.

Principal Display Panel 60 Ml Bottle Label

clear

days ahead

philosophy ®: total clarity is when

your head and your heart come

together wanting and needing the

exact same things. opposition and

uncertainty disappear, and perfect

balance is restored.

oil-free salicylic acid

acne treatment & moisturizer

60 ml/2 fl. oz.

Principal Display Panel 60 Ml Sleeve Label

philosophy

acne treatment

oil-free moisturizer

salicylic acid


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 the 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 (1.0%)

Inactive Ingredients (Inactive ingredients)

water, dimethicone, polysilicone-11, butylene glycol, acacia decurrens/jojoba/sunflower seed wax/polyglyceryl-3 esters, caprylic/capric triglyceride, sodium acrylates copolymer, squalane, lecithin, oligopeptide- 10, tocopheryl acetate, trimethylpentanediol/adipic acid copolymer, octyldodecyl neopentanoate, ceteareth-20, cetearyl alcohol, polysorbate 60, ppg-12/smdi copolymer, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, ethoxydiglycol, sodium hydroxide, disodium edta, 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.
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 60 Ml Box Label (Principal Display Panel - 60 ml Box Label)

clear

days ahead

philosophy ®: total clarity is

when your head and your

heart come together wanting

and needing the exact

same things. opposition and

uncertainty disappear, and

perfect balance is restored.

oil-free salicylic acid

acne treatment & moisturizer

60 ml/2 fl. oz.

Principal Display Panel 60 Ml Bottle Label (Principal Display Panel - 60 ml Bottle Label)

clear

days ahead

philosophy ®: total clarity is when

your head and your heart come

together wanting and needing the

exact same things. opposition and

uncertainty disappear, and perfect

balance is restored.

oil-free salicylic acid

acne treatment & moisturizer

60 ml/2 fl. oz.

Principal Display Panel 60 Ml Sleeve Label (Principal Display Panel - 60 ml Sleeve Label)

philosophy

acne treatment

oil-free moisturizer

salicylic acid


Advanced Ingredient Data


Raw Label Data

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