SPL v4
SPL
SPL Set ID 781050c2-9b10-a63d-e053-2a91aa0a6e89
Route
TOPICAL
Published
Effective Date 2018-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Witch Hazel Pine Needle Oil (pinus Sylvestris) Butylene Glycol Eucalyptus Oil Magnesium Disodium Edta Fd&c Yellow No. 5 Fd&c Blue No. 1 Aminomethyl Propanediol Sage Oil Water Willow Bark Aloe Arborescens Leaf Isoceteth-20 Ethoxydiglycol Behenate Allantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-08-26

Description

Warnings: For External Use Only


Medication Information

Warnings and Precautions

Warnings: For External Use Only

Description

Warnings: For External Use Only

Uses

Treats acne and helps prevent new acne blemishes from forming

Section 50565-1

Keep out of reach of children. if swallowed, seek medical help or contact a Poison Control Center

Section 50567-7

When using this product keep out of eyes. If contact occurs, flush thoroughly with water

Section 51945-4

Section 55105-1

Acne Treatment

Section 55106-9

Salicylic Acid - 2%

Directions:

use 1 to 3 times daily on cleansed skin. mist the skin concentratikng on areas of acne breakout. do not rinse. allow to dry thoroughly. if bothersome dryness or peeling occurs, reduce application to once a day.

Inactive Ingredients:

Water, SD Alcohol 40, Isoceteth-20, Ethoxydiglycol, Aloe Leaf Juice, Allantoin, Willow Bark Extract, Witch Hazel Extract, Sage Extract, Eucalyptus Oil, Pine Tree Oil, Butylene Glycol, Aminomethyl Propanol, Disodium EDTA, FD&C Yellow 5, FD&C Blue 1


Structured Label Content

Uses

Treats acne and helps prevent new acne blemishes from forming

Warnings and Precautions (34071-1)

Warnings: For External Use Only

Section 50565-1 (50565-1)

Keep out of reach of children. if swallowed, seek medical help or contact a Poison Control Center

Section 50567-7 (50567-7)

When using this product keep out of eyes. If contact occurs, flush thoroughly with water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Acne Treatment

Section 55106-9 (55106-9)

Salicylic Acid - 2%

Directions:

use 1 to 3 times daily on cleansed skin. mist the skin concentratikng on areas of acne breakout. do not rinse. allow to dry thoroughly. if bothersome dryness or peeling occurs, reduce application to once a day.

Inactive Ingredients:

Water, SD Alcohol 40, Isoceteth-20, Ethoxydiglycol, Aloe Leaf Juice, Allantoin, Willow Bark Extract, Witch Hazel Extract, Sage Extract, Eucalyptus Oil, Pine Tree Oil, Butylene Glycol, Aminomethyl Propanol, Disodium EDTA, FD&C Yellow 5, FD&C Blue 1


Advanced Ingredient Data


Raw Label Data

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