Acne Free Sensitive Skin 24 Hr Acne Clearing System Kit

Acne Free Sensitive Skin 24 Hr Acne Clearing System Kit
SPL v6
SPL
SPL Set ID c9397a25-8fed-48d0-e053-2a95a90ab495
Route
TOPICAL
Published
Effective Date 2021-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (15 mg) Benzoyl Peroxide (30 mg)
Inactive Ingredients
Water Sodium Cocoyl Isethionate Stearic Acid Cocamidopropyl Betaine Sodium Lauroamphoacetate Disodium Laureth Sulfosuccinate Glycol Distearate Benzyl Alcohol Oat Phytate Sodium Zinc Pidolate Glycerin Sorbic Acid Ethyl Vanillin Butylene Glycol Pseudopterogorgia Elisabethae Aminomethylpropanol Ethyl Macadamiate Propanediol Phenoxyethanol C13-14 Isoparaffin Levomenol Laureth-7 Allantoin Tea Tree Oil Methylisothiazolinone Hyaluronate Sodium Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Sodium Hydroxide Ginger

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-12-01

Description

Salicylic acid 1.5%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic acid 1.5%

Use

for the treatment of acne

Warnings

For external use only

Directions

• use every morning and evening

• apply a dime-size amount to damp skin and gently massage, avoiding the eye area

• rinse well

• if bothersome dryness or peeling occurs, reduce application use

• may be used on chest or back

80861 008 01

80861 009 01

Do Not Use 

if you

• have very sensitive skin

• are sensitive to benzoyl peroxide

Kit 80861 007 01

Active Ingredient

Salicylic acid 1.5%

Other Information

store at 60°−95° F (15°−35° C)

Inactive Ingredients

water, sodium cocoyl isethionate, stearic acid, cocamidopropyl betaine, sodium lauroamphoacetate, disodium laureth sulfosuccinate, glycol distearate, polyacrylate-1 crosspolymer, benzyl alcohol, avena sativa (oat) kernel extract, sodium phytate, zinc PCA, glycerin, sorbic acid, ethyl vanillin, butylene glycol, sea whip extract, aminomethyl propanol

Questions Or Comments?

1-888-768-2913

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

skin irritation becomes severe

Keep Out of Reach of Children.

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

Keep Out of Reach of Children. 

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


Structured Label Content

Use

for the treatment of acne

Purpose

Acne treatment

Warnings

For external use only

Directions

• use every morning and evening

• apply a dime-size amount to damp skin and gently massage, avoiding the eye area

• rinse well

• if bothersome dryness or peeling occurs, reduce application use

• may be used on chest or back

80861 008 01 (80861-008-01)

80861 009 01 (80861-009-01)

Do Not Use  (Do not use )

if you

• have very sensitive skin

• are sensitive to benzoyl peroxide

Kit 80861 007 01 (KIT 80861-007-01)

Active Ingredient (Active ingredient)

Salicylic acid 1.5%

Other Information (Other information)

store at 60°−95° F (15°−35° C)

Inactive Ingredients (Inactive ingredients)

water, sodium cocoyl isethionate, stearic acid, cocamidopropyl betaine, sodium lauroamphoacetate, disodium laureth sulfosuccinate, glycol distearate, polyacrylate-1 crosspolymer, benzyl alcohol, avena sativa (oat) kernel extract, sodium phytate, zinc PCA, glycerin, sorbic acid, ethyl vanillin, butylene glycol, sea whip extract, aminomethyl propanol

Questions Or Comments? (Questions or comments?)

1-888-768-2913

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.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

skin irritation becomes severe

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.

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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