Replenix®

Replenix®
SPL v3
SPL
SPL Set ID 8dc2d27d-3cc4-4874-b4c2-32607849b205
Route
TOPICAL
Published
Effective Date 2019-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Phenoxyethanol Water Sodium Benzoate Sodium C14-16 Olefin Sulfonate Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-11-01

Description

Drug Facts

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Drug Facts

Uses

BP Wash is a therapeutic combination of sudsing cleanser and benzoyl peroxide for the treatment of acne.

Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately.
Section 50567-7
  • When using this product avoid unnecessary sun exposure and use a sunscreen.
  • For external use only.
  • Keep away from eyes, lips, and mouth.
  • If irritation or sensitivity develops, discontinue use and consult a doctor.
  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
  • May bleach fabrics.
Directions
  • Shake well. Wet affected area, wash, and rinse well.
  • Use once or twice daily or as directed by a physician.
  • If bothersome drying or peeling occurs, reduce applications.
  • If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.
Active Ingredients

Benzoyl Peroxide USP, 10%

Inactive Ingredients

Carbomer, Phenoxyethanol, Purified Water, Sodium Benzoate, Sodium C14-16 Olefin Sulfonate, Stearic Acid USP.

Principal Display Panel 200 Ml Tube Label

REPLENiX®

ACNE SOLUTIONS

Acne Wash

Benzoyl Peroxide USP, 10%

Net 6.7 fl. oz. (200 ml)

Topix Pharmaceuticals, Inc.

N. Amityville, NY 11701


Structured Label Content

Uses

BP Wash is a therapeutic combination of sudsing cleanser and benzoyl peroxide for the treatment of acne.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately.
Section 50567-7 (50567-7)
  • When using this product avoid unnecessary sun exposure and use a sunscreen.
  • For external use only.
  • Keep away from eyes, lips, and mouth.
  • If irritation or sensitivity develops, discontinue use and consult a doctor.
  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
  • May bleach fabrics.
Purpose

Acne treatment

Directions
  • Shake well. Wet affected area, wash, and rinse well.
  • Use once or twice daily or as directed by a physician.
  • If bothersome drying or peeling occurs, reduce applications.
  • If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.
Active Ingredients (Active ingredients)

Benzoyl Peroxide USP, 10%

Inactive Ingredients (Inactive ingredients)

Carbomer, Phenoxyethanol, Purified Water, Sodium Benzoate, Sodium C14-16 Olefin Sulfonate, Stearic Acid USP.

Principal Display Panel 200 Ml Tube Label (PRINCIPAL DISPLAY PANEL - 200 ml Tube Label)

REPLENiX®

ACNE SOLUTIONS

Acne Wash

Benzoyl Peroxide USP, 10%

Net 6.7 fl. oz. (200 ml)

Topix Pharmaceuticals, Inc.

N. Amityville, NY 11701


Advanced Ingredient Data


Raw Label Data

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