So Fresh So Clean Moderate Acne Treatment

So Fresh So Clean Moderate Acne Treatment
SPL v2
SPL
SPL Set ID 182ed8a4-083e-2776-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1 g)
Inactive Ingredients
Aloe Vera Leaf Matricaria Recutita Dmdm Hydantoin Phenoxyethanol .alpha.-tocopherol Acetate Water Glycerin Propylene Glycol Polysorbate 20 Hexylene Glycol Benzyl Alcohol Sodium Lauroamphoacetate Green Tea Leaf Polyoxyl 40 Hydrogenated Castor Oil Edetate Disodium Iodopropynyl Butylcarbamate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-06-25

Description

ACNE WIPES 35 THICK WIPES

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

ACNE WIPES 35 THICK WIPES

Use

For the treatment of acne

Section 51945-4

Section 53413-1

For questions or comments or to report serious side effects:

P.O. Box 230258

Brooklyn NY 11223

Warnings

For external use only.

Directions
  • Cleanse skin thoroughly before applying medication. Remove wipe. Unfold and wipe over entire affected area.
  • Reseal label on package to maintain freshness.
Active Ingredient

Salicylic Acid 1%

Other Information
  • Store at room temperature 60-90 F (15-35 C)
So Fresh So Clean

ACNE WIPES

35 THICK WIPES

Inactive Ingredients

Aqua (Water), Glycerin, Propylene Glycol, Dodecyl Polyglucoside, Polysorbate 20, Hexylene Glycol, Benzyl Alcohol, Sodium Lauroamphoacetate, Aloe Barbadensis (Aloe Vera) Leaf Extract, White Tea Extract, Chamomilla Recutita (Chamomile) Extract, Glydant DMDMH, Phenoxyethanol, Peg-40 Hydrogenated Castor Oil, Tocopheryl Acetate (Vitamin E), Disodium EDTA, Fragrance, Iodopropynyl Butycarbamate.

When Using This Product
  • With other topical acne medications, at the same time or immediately afterwards, increased skin dryness, redness or irritation may occur. If this happens, only one medication should be used ules directed by a doctor.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep away from mouth and lips.
Stop Use and Ask A Doctor If

skin irritation occurs

Keep Out of Reach of Children.

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


Structured Label Content

Use

For the treatment of acne

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

For questions or comments or to report serious side effects:

P.O. Box 230258

Brooklyn NY 11223

Purpose

Acne Treatment

Warnings

For external use only.

Directions
  • Cleanse skin thoroughly before applying medication. Remove wipe. Unfold and wipe over entire affected area.
  • Reseal label on package to maintain freshness.
Active Ingredient (Active ingredient)

Salicylic Acid 1%

Other Information (Other information)
  • Store at room temperature 60-90 F (15-35 C)
So Fresh So Clean (SO FRESH SO CLEAN)

ACNE WIPES

35 THICK WIPES

Inactive Ingredients (Inactive ingredients)

Aqua (Water), Glycerin, Propylene Glycol, Dodecyl Polyglucoside, Polysorbate 20, Hexylene Glycol, Benzyl Alcohol, Sodium Lauroamphoacetate, Aloe Barbadensis (Aloe Vera) Leaf Extract, White Tea Extract, Chamomilla Recutita (Chamomile) Extract, Glydant DMDMH, Phenoxyethanol, Peg-40 Hydrogenated Castor Oil, Tocopheryl Acetate (Vitamin E), Disodium EDTA, Fragrance, Iodopropynyl Butycarbamate.

When Using This Product (When using this product)
  • With other topical acne medications, at the same time or immediately afterwards, increased skin dryness, redness or irritation may occur. If this happens, only one medication should be used ules directed by a doctor.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep away from mouth and lips.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

skin irritation occurs

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

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


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