111medco 2% Salicylic Acid Cleansing Bar

111medco 2% Salicylic Acid Cleansing Bar
SPL v3
SPL
SPL Set ID 6ba7dd8f-b59f-4dfb-b55e-c7fe65a54d8a
Route
TOPICAL
Published
Effective Date 2022-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Sodium Palmate Sodium Cocoate Sodium Palm Kernelate Glycerin Sodium Chloride Pentasodium Pentetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-01

Description

Salicylic acid 2%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic acid 2%

Uses
  • For the treatment of acne
  • Reduces the number of acne pimples and allows skin to heal
  • Penetrates pores to clear acne blemishes
  • Dries up acne pimples
  • Helps keep skin clear of new acne blemishes, acne pimples, whiteheads, and blackheads
Warnings

For external use only

Directions
  • Apply liberally over wet skin with a clean wash cloth or body puff, concentrating on areas prone to acne, avoiding contact with eye Rinse thoroughly and pat dry with a clean towel
  • Because bothersome dryness of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed 
  • If bothersome drying or peeling occurs, reduce application to once a day or every other day
Active Ingredient

Salicylic acid 2%

Inactive Ingredients

Sodium palmate, sodium cocoate*, sodium palm kernelate*, agua, glycerin, pink grapefruit extract, sodium chloride, pentasodium pentetate. (*may contain this ingredient)

When Using This Product

skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a  healthcare provider.

Keep Out of Reach of Children.

If swallowed, get medial help or contact a Poison Control Center right away.

Package Labeling: 111medco 2% Salicylic Acid Cleansing Bar, 4oz/113g (72811 000 04)


Structured Label Content

Uses
  • For the treatment of acne
  • Reduces the number of acne pimples and allows skin to heal
  • Penetrates pores to clear acne blemishes
  • Dries up acne pimples
  • Helps keep skin clear of new acne blemishes, acne pimples, whiteheads, and blackheads
Purpose

Acne treatment

Warnings

For external use only

Directions
  • Apply liberally over wet skin with a clean wash cloth or body puff, concentrating on areas prone to acne, avoiding contact with eye Rinse thoroughly and pat dry with a clean towel
  • Because bothersome dryness of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed 
  • If bothersome drying or peeling occurs, reduce application to once a day or every other day
Active Ingredient (Active ingredient)

Salicylic acid 2%

Inactive Ingredients (Inactive ingredients)

Sodium palmate, sodium cocoate*, sodium palm kernelate*, agua, glycerin, pink grapefruit extract, sodium chloride, pentasodium pentetate. (*may contain this ingredient)

When Using This Product (When using this product)

skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a  healthcare provider.

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

If swallowed, get medial help or contact a Poison Control Center right away.

Package Labeling: 111medco 2% Salicylic Acid Cleansing Bar, 4oz/113g (72811 000 04) (Package Labeling: 111MedCo 2% Salicylic Acid Cleansing Bar, 4oz/113g (72811-000-04))


Advanced Ingredient Data


Raw Label Data

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