Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 6e53dad7-5fa8-4fe1-ac6d-11921458d6a0
Route
TOPICAL
Published
Effective Date 2011-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 mL)
Inactive Ingredients
Water Cetyl Alcohol Steareth-15 Polyethylene Glycols Glycolic Acid Glycerin Polysorbate 60 Steareth-21 Butylated Hydroxytoluene Neopentyl Glycol Dicaprate Cocamidopropyl Pg-dimonium Chloride Phosphate Potassium Cetyl Phosphate Edetate Disodium Xanthan Gum Sodium Hydroxide Agar Menthol Benzalkonium Chloride Ferric Oxide Red Mica Titanium Dioxide Fd&c Red No. 40 D&c Red No. 33 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-08-03

Description

SALICYLIC ACID 2.0%

Purpose

ACNE TREATMENT


Medication Information

Purpose

ACNE TREATMENT

Description

SALICYLIC ACID 2.0%

Uses

For the treatment of Acne

Warnings

FOR EXTERNAL USE ONLY

Directions

CLEANSE TWO TIMES A DAY. WET FACE. APPLY TO HANDS ADD WATER AND WORK INTO LATHER. MASSAGE FACE GENTLY. RINSE WELL.

Label Copy

Active Ingredient

SALICYLIC ACID 2.0%

Inactive Ingredients

WATER, CETYL ALCOHOL, PPG-15 STEARYL ETHER, POLYETHYLENE, GLYCOLIC ACID, GLYCERIN, POLYSORBATE 60, STEREATH-21, C12-15 ALKYL LACTATE, CETYL LACTATE, BHT, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE, POTASSIUM CETYL PHOSPHATE, DISODIUM EDTA, XANTHAN GUM, SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE, SODIUM HYDROXIDE, AGAR, MENTHOL, BENZALKONIUM CHLORIDE, MICA, TITANIUM DIOXIDE, RED 40 (CI 16035), RED 33  (CI 17200), YELLOW 5 (CI 19140),  FRAGRANCE  (PARFUM)

Questions Or Comments

1-866-695-3030

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR  CONTACT POISON CONTROL CENTER IMMEDIATELY.

Stop Using This Product and Ask Doctor If

IRRITATION OR REDNESS DEVELOPS AND LASTS

Ask Doctor Or Pharmacist Before Use 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.


Structured Label Content

Uses (USES)

For the treatment of Acne

Purpose (PURPOSE)

ACNE TREATMENT

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Directions (DIRECTIONS)

CLEANSE TWO TIMES A DAY. WET FACE. APPLY TO HANDS ADD WATER AND WORK INTO LATHER. MASSAGE FACE GENTLY. RINSE WELL.

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

SALICYLIC ACID 2.0%

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, CETYL ALCOHOL, PPG-15 STEARYL ETHER, POLYETHYLENE, GLYCOLIC ACID, GLYCERIN, POLYSORBATE 60, STEREATH-21, C12-15 ALKYL LACTATE, CETYL LACTATE, BHT, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE, POTASSIUM CETYL PHOSPHATE, DISODIUM EDTA, XANTHAN GUM, SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE, SODIUM HYDROXIDE, AGAR, MENTHOL, BENZALKONIUM CHLORIDE, MICA, TITANIUM DIOXIDE, RED 40 (CI 16035), RED 33  (CI 17200), YELLOW 5 (CI 19140),  FRAGRANCE  (PARFUM)

Questions Or Comments (QUESTIONS OR COMMENTS)

1-866-695-3030

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR  CONTACT POISON CONTROL CENTER IMMEDIATELY.

Stop Using This Product and Ask Doctor If (STOP USING THIS PRODUCT AND ASK DOCTOR IF)

IRRITATION OR REDNESS DEVELOPS AND LASTS

Ask Doctor Or Pharmacist Before Use If You Are (ASK DOCTOR OR PHARMACIST BEFORE USE 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.


Advanced Ingredient Data


Raw Label Data

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