drug listing

drug listing
SPL v1
SPL
SPL Set ID a0e5126a-0bb6-43b7-806b-0e7b30bc41f9
Route
topical
Published
Effective Date 2012-06-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (2 mL)
Inactive Ingredients
water sodium c14-16 olefin sulfonate glycerin cocamidopropyl betaine high density polyethylene carbomer copolymer type a chamomile propylene glycol green tea leaf sodium hydroxide edetate disodium fd&c yellow no. 6 fd&c red no. 40 fd&c blue no. 1 d&c red no. 33 fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2012-06-07

Purpose

ACNE TREATMENT

Description

SALICYLIC ACID 2%


Medication Information

Warnings

FOR EXTERNAL USE ONLY.

Uses

FOR THE TREATMENT OF ACNE.

Purpose

ACNE TREATMENT

Directions

USE DAILY IN THE SHOWER OR BATH. FOR MAXIMUM LATHER, MASSAGE OVER WET SKIN WITH A WASHCLOTH OR BODY PUFF, CONCENTRATING ON AREAS PRONE TO BREAKOUTS. RINSE WELL.

Description

SALICYLIC ACID 2%

Label Copy

Active Ingredient

SALICYLIC ACID 2%

Questions/comments?

1-866-695-3030

Inactive Ingredients:

WATER (AQUA), SODIUM C14-16 OLEFIN SULFONATE, GLYCERIN, COCAMIDOPROPYL BETAINE, POLYETHYLENE, ACRYLATES COPOLYMER, MATRICARIA (CHAMOMILLA RECUTITA) FLOWER EXTRACT, PROPYLENE GLYCOL, CAMELLIA SINENSIS LEAF EXTRACT, SODIUM HYDROXIDE, DISODIUM EDTA, YELLOW 6 (CI 15985), RED 40 (CI 16035), BLUE 1 (CI 42090), RED 33 (CI 17200), YELLOW 5 (CI 19140), FRAGRANCE (PARFUM).

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 A 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

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Uses (USES)

FOR THE TREATMENT OF ACNE.

Purpose (PURPOSE)

ACNE TREATMENT

Directions (DIRECTIONS)

USE DAILY IN THE SHOWER OR BATH. FOR MAXIMUM LATHER, MASSAGE OVER WET SKIN WITH A WASHCLOTH OR BODY PUFF, CONCENTRATING ON AREAS PRONE TO BREAKOUTS. RINSE WELL.

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

SALICYLIC ACID 2%

Questions/comments? (QUESTIONS/COMMENTS?)

1-866-695-3030

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), SODIUM C14-16 OLEFIN SULFONATE, GLYCERIN, COCAMIDOPROPYL BETAINE, POLYETHYLENE, ACRYLATES COPOLYMER, MATRICARIA (CHAMOMILLA RECUTITA) FLOWER EXTRACT, PROPYLENE GLYCOL, CAMELLIA SINENSIS LEAF EXTRACT, SODIUM HYDROXIDE, DISODIUM EDTA, YELLOW 6 (CI 15985), RED 40 (CI 16035), BLUE 1 (CI 42090), RED 33 (CI 17200), YELLOW 5 (CI 19140), FRAGRANCE (PARFUM).

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 A 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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