Oil-free Foaming Acne Wash

Oil-free Foaming Acne Wash
SPL v3
SPL
SPL Set ID 8c340b1c-fd42-42c9-979b-920ffacdce28
Route
TOPICAL
Published
Effective Date 2023-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (3 g)
Inactive Ingredients
Water Sodium C14-16 Olefin Sulfonate Cocamidopropyl Betaine Propylene Glycol Sodium Lauryl Sulfate Edetate Disodium Sodium Hydroxide Melaleuca Alternifolia Leaf Fd&c Blue No. 1 Fd&c Yellow No. 5 Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Sodium Chloride Microcrystalline Wax Dmdm Hydantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Completed Since 2013-11-20 Until 2023-05-19

Description

Active Ingredient                             Purpose Salicylic Acid 2.0% ................. Acne Treatment


Medication Information

Warnings and Precautions

Warnings

For external use only

When using this product and other topical acne medications at the same time or immediately following use of this product, dryness or irritation of the skin may be increased. If this occurs, only one medication should be used unless directed by a doctor.

Indications and Usage

This XtraCare foaming acne facial scrub gently cleanses breakouts you already have and helps prevent them from returning. It works deep to clean and soothe without overdrying or irritating skin. Rinses clean, leaving no residue to clog pores.

Uses

For acne-prone skin.

Dosage and Administration

Directions

Wet face. Dispense into palm, apply to face and massage gently. Rinse thoroughly and pat dry.

Description

Active Ingredient                             Purpose Salicylic Acid 2.0% ................. Acne Treatment

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Section 51945-4

Section 55105-1

XtraCare Oil-Free Foaming Acne Wash Facial Scrub

WITH TEA TREE OIL

helps clear breakouts

Salicylic Acid 2%

Net Wt 5.3 Oz (150g)

Section 55106-9

Active Ingredient                             Purpose

Salicylic Acid 2.0% ................. Acne Treatment

Section 60561-8

Other Information

store at 20o to 25oC (68o to 77oF)

DISTRIBUTED BY

REJOICE INTERNATIONAL INC

48325 BINGHAMPTON DR

NORTHVILLE, MI 48168 USA

MADE IN CHINA

inactive Ingredients

water, sodium c14-16 olefin sulfonate, cocamidopropyl betaine, acrylates copolymer, sodium chloride, microcrystalline wax, DMDM hydantoin, fragrance, disodium EDTA, sodium lauryl sulfate, sodium hydroxide, propylene glycol, melaleuca altemifolia (tea tree) leaf oil, fd&c blue no.1, fd&c yellow no.5.


Structured Label Content

Indications and Usage (34067-9)

This XtraCare foaming acne facial scrub gently cleanses breakouts you already have and helps prevent them from returning. It works deep to clean and soothe without overdrying or irritating skin. Rinses clean, leaving no residue to clog pores.

Uses

For acne-prone skin.

Dosage and Administration (34068-7)

Directions

Wet face. Dispense into palm, apply to face and massage gently. Rinse thoroughly and pat dry.

Warnings and Precautions (34071-1)

Warnings

For external use only

When using this product and other topical acne medications at the same time or immediately following use of this product, dryness or irritation of the skin may be increased. If this occurs, only one medication should be used unless directed by a doctor.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

XtraCare Oil-Free Foaming Acne Wash Facial Scrub

WITH TEA TREE OIL

helps clear breakouts

Salicylic Acid 2%

Net Wt 5.3 Oz (150g)

Section 55106-9 (55106-9)

Active Ingredient                             Purpose

Salicylic Acid 2.0% ................. Acne Treatment

Section 60561-8 (60561-8)

Other Information

store at 20o to 25oC (68o to 77oF)

DISTRIBUTED BY

REJOICE INTERNATIONAL INC

48325 BINGHAMPTON DR

NORTHVILLE, MI 48168 USA

MADE IN CHINA

inactive Ingredients (Inactive ingredients)

water, sodium c14-16 olefin sulfonate, cocamidopropyl betaine, acrylates copolymer, sodium chloride, microcrystalline wax, DMDM hydantoin, fragrance, disodium EDTA, sodium lauryl sulfate, sodium hydroxide, propylene glycol, melaleuca altemifolia (tea tree) leaf oil, fd&c blue no.1, fd&c yellow no.5.


Advanced Ingredient Data


Raw Label Data

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