Replenix®

Replenix®
SPL v1
SPL
SPL Set ID f449e020-a4d8-4a1b-82eb-4dc59e99b8d4
Route
TOPICAL
Published
Effective Date 2024-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Water Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Sodium Lauroyl Sarcosinate Sodium Hydroxymethylglycinate Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-13

Description

Drug Facts

Purpose

Anti-acne


Medication Information

Purpose

Anti-acne

Description

Drug Facts

Uses
  • Topical acne medication.
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.
Directions
  • Cleanse the skin thoroughly before applying.
  • Apply a thin layer daily, then gradually increase to two or three times daily.
  • 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 Ingredient

Benzoyl Peroxide, USP 10%

Inactive Ingredients

Carbomer, Purified Water, Sodium Hydroxymethylglycinate, Sodium Lauroyl Sarcosinate, Stearic Acid.

Principal Display Panel 57 G Bottle Label

REPLENiX®

Acne

BP ACNE GEL

10% SPOT

TREATMENT

MEDICAL GRADE INGREDIENTS

Benzoyl Peroxide USP 10%

DERMATOLOGIST

• RECOMMENDED •

40 YRS

Net 2 oz (57 g)


Structured Label Content

Uses
  • Topical acne medication.
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.
Purpose

Anti-acne

Directions
  • Cleanse the skin thoroughly before applying.
  • Apply a thin layer daily, then gradually increase to two or three times daily.
  • 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 Ingredient (Active ingredient)

Benzoyl Peroxide, USP 10%

Inactive Ingredients (Inactive ingredients)

Carbomer, Purified Water, Sodium Hydroxymethylglycinate, Sodium Lauroyl Sarcosinate, Stearic Acid.

Principal Display Panel 57 G Bottle Label (PRINCIPAL DISPLAY PANEL - 57 g Bottle Label)

REPLENiX®

Acne

BP ACNE GEL

10% SPOT

TREATMENT

MEDICAL GRADE INGREDIENTS

Benzoyl Peroxide USP 10%

DERMATOLOGIST

• RECOMMENDED •

40 YRS

Net 2 oz (57 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)