SPL v6
SPL
SPL Set ID a47e4888-9e1f-4344-aeb6-a776c154dd39
Route
TOPICAL
Published
Effective Date 2021-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 mg)
Inactive Ingredients
Water Glycolic Acid Phellodendron Amurense Bark Pear Juice Rehmannia Glutinosa Root Houttuynia Cordata Flowering Top Azadirachta Indica Leaf Scutellaria Baicalensis Root Soybean

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-05-21

Description

Salicylic acid 2.0%

Purpose

Acne medication


Medication Information

Purpose

Acne medication

Description

Salicylic acid 2.0%

Uses
  • For the treatment of acne
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

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.

Warnings

For external use only

Directions
  • 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 below
  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Active Ingredient

Salicylic acid 2.0%

Inactive Ingredients

water, glyolic acid, phelledendron amurense bark extract, pear juice ferment filtrate, rehmannia chinensis root extract, houttuynia cordata extract, melia azadirachta leaf extract, scutellaria baicalensis root extract, glycine soja (soybean) seed extract

Package Labels 2 Fl Oz (60 Ml) Ndc 79061 042 01

Bottle Label

RELUMINS

PRO CLEAR FOAM

Advanced Botanical Formula with 2% Salicylic Acid

Complete Facial Care For Blemish-Prone Skin

Penetrates Deep • Promotes Clear Skin

PROFESSIONAL SKIN CARE

2 fl oz (60 ml)

EXP:

LOT:

Relumins Labs

USA

183 Locust Ave

West Long Branch, NJ 07764

www.relumins.com

Carton Label

RELUMINS

PRO CLEAR FOAM

Advanced Botanical Formula

Salicylic Acid Acne Treatment

Complete Facial Care For Blemish-Prone Skin

Penetrates Deep • Promotes Clear Skin

PROFESSIONAL SKIN CARE

2 fl oz (60 ml)

EXP:

LOT:

Relumins Labs

USA

183 Locust Ave

West Long Branch, NJ 07764

www.relumins.com


Structured Label Content

Uses
  • For the treatment of acne
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

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.

Purpose

Acne medication

Warnings

For external use only

Directions
  • 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 below
  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Active Ingredient (Active ingredient)

Salicylic acid 2.0%

Inactive Ingredients (Inactive ingredients)

water, glyolic acid, phelledendron amurense bark extract, pear juice ferment filtrate, rehmannia chinensis root extract, houttuynia cordata extract, melia azadirachta leaf extract, scutellaria baicalensis root extract, glycine soja (soybean) seed extract

Package Labels 2 Fl Oz (60 Ml) Ndc 79061 042 01 (Package Labels - 2 fl oz (60 mL) - NDC 79061-042-01)

Bottle Label

RELUMINS

PRO CLEAR FOAM

Advanced Botanical Formula with 2% Salicylic Acid

Complete Facial Care For Blemish-Prone Skin

Penetrates Deep • Promotes Clear Skin

PROFESSIONAL SKIN CARE

2 fl oz (60 ml)

EXP:

LOT:

Relumins Labs

USA

183 Locust Ave

West Long Branch, NJ 07764

www.relumins.com

Carton Label

RELUMINS

PRO CLEAR FOAM

Advanced Botanical Formula

Salicylic Acid Acne Treatment

Complete Facial Care For Blemish-Prone Skin

Penetrates Deep • Promotes Clear Skin

PROFESSIONAL SKIN CARE

2 fl oz (60 ml)

EXP:

LOT:

Relumins Labs

USA

183 Locust Ave

West Long Branch, NJ 07764

www.relumins.com


Advanced Ingredient Data


Raw Label Data

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