SPL v6
SPL
SPL Set ID b762cb3d-72b9-468c-9dac-fa960ef972f0
Route
TOPICAL
Published
Effective Date 2014-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Brucine Sulfate Water Alcohol Glycerin Xanthan Gum Peppermint .alpha.-tocopherol Acetate Wheat Germ Oil Glycolic Acid Tert-butyl Alcohol Polysorbate 20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Completed Since 2014-10-22 Until 2021-09-01

Description

Acne Treatment Gel

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Acne Treatment Gel

Use

For the management of acne.

Clears up most acne pimples, blackheads, and whiteheads and allows skin to heal.

Penetrates pores to eliminate most acne blemishes.

Helps prevent new acne pimples.

Section 51945-4

Warnings

For external use only.

Directions

Each night, dispense a small amount of gel onto the fingertips.

Spread gel sparingly on the face and other affected areas using small circular motions avoiding the eyes.

Repeat after perspiration or makeup use.

If dryness occurs, reduce frequency to once each day.

Drug Facts

Acne Treatment Gel

Active Ingredients

Salicylic Acid, 2%

Inactive Ingredients

Purified Water, Alcohol, Glycerin, Xanthan Gum, Polysorbate 20, Peppermint Oil, (.Alpha.-Tocopherol Acetate), Wheat Germ Oil, Glycolic Acid, Tert-Butyl Alcohol, Brucine Sulfate.

Questions Or Comments

281-835-8051

M-F 8 AM to 5 PM

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.

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Sensitivity Test for A New User

Apply product sparingly to one or two small affected areas during the first 3 days.

If no discomfort occurs, follow the directions stated above.


Structured Label Content

Use

For the management of acne.

Clears up most acne pimples, blackheads, and whiteheads and allows skin to heal.

Penetrates pores to eliminate most acne blemishes.

Helps prevent new acne pimples.

Section 51945-4 (51945-4)

Purpose

Acne Treatment

Warnings

For external use only.

Directions

Each night, dispense a small amount of gel onto the fingertips.

Spread gel sparingly on the face and other affected areas using small circular motions avoiding the eyes.

Repeat after perspiration or makeup use.

If dryness occurs, reduce frequency to once each day.

Drug Facts

Acne Treatment Gel

Active Ingredients

Salicylic Acid, 2%

Inactive Ingredients

Purified Water, Alcohol, Glycerin, Xanthan Gum, Polysorbate 20, Peppermint Oil, (.Alpha.-Tocopherol Acetate), Wheat Germ Oil, Glycolic Acid, Tert-Butyl Alcohol, Brucine Sulfate.

Questions Or Comments (Questions or comments)

281-835-8051

M-F 8 AM to 5 PM

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.

Keep Out of Reach of Children (Keep out of reach of children)

KEEP OUT OF REACH OF CHILDREN

Sensitivity Test for A New User (Sensitivity test for a new user)

Apply product sparingly to one or two small affected areas during the first 3 days.

If no discomfort occurs, follow the directions stated above.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)