Recovery Antiseptic Skin Prep

Recovery Antiseptic Skin Prep
SPL v6
SPL
SPL Set ID 94c5ea07-6bdb-42c6-8ce0-0d0711bd7036
Route
TOPICAL
Published
Effective Date 2020-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (3.0 g)
Inactive Ingredients
Water Lauryl Glucoside Propylene Glycol Cocamidopropyl Betaine Ppg-2 Hydroxyethyl Cocamide Xanthan Gum Citric Acid Monohydrate Edetate Sodium Bis-diglyceryl Polyacyladipate-2

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-26

Description

DRUG FACTS


Medication Information

Warnings and Precautions

WARNINGS: FOR EXTERNAL USE ONLY.

DO NOT INGEST.

Indications and Usage

Uses: Antiseptic cleanser.

Decreases harmful bacteria or germs.

Dosage and Administration

Directions: Apply as needed and scrub thoroughly for at least 30 seconds. Rinse well and repeat. For best results, do not dilute.

Other information: Avoid freezing. Store between 4˚C and 30˚C (40˚F and 86˚F)

Description

DRUG FACTS

Section 42229-5

DRUG FACTS

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Section 50566-9

Stop use and ask doctor if: Irritation, rash, or other allergic reaction occurs.

Section 50567-7

When using this product: Do not use in

or near the eyes and mouth (oral mucosa). In

case of eye contact, flush eyes with water.

Section 50570-1

Do not use if: you are allergic or sensitive to any of the listed ingredients.

Section 51727-6

Inactive ingredients: Water (aqua), Lauryl Glucoside, Propylene Glycol, Cocamidopropyl Betaine, PPG-2 Hydroxyethyl Cocamide, Xanthan Gum, Citric Acid, Tetrasodium EDTA, Bis-Diglyceryl Polyacyladipate-2

Section 55105-1

Purpose: Antiseptic

Section 55106-9

Active ingredient: Chloroxylenol 3%

Section 60561-8

Other information: Avoid freezing. Store between 4˚C and 30˚C (40˚F and 86˚F)

Principal Display Package Labeling

RECOVERY

ANTISEPTIC

SKIN PREP

VEGAN-FRIENDLY

FREE OF ALCOHOL, PARABENS,

FRAGRANCES & DYES

30 FL. OZ. (900 mL)

NDC: 49436-377-30

recoveryaftercare.com

@recoveryaftercare

Distributed by

Recovery Aftercare, Inc.

Hanover, MD 21076

Made in Canada

©Recovery Aftercare, Inc. 2020



res


Structured Label Content

Indications and Usage (34067-9)

Uses: Antiseptic cleanser.

Decreases harmful bacteria or germs.

Dosage and Administration (34068-7)

Directions: Apply as needed and scrub thoroughly for at least 30 seconds. Rinse well and repeat. For best results, do not dilute.

Other information: Avoid freezing. Store between 4˚C and 30˚C (40˚F and 86˚F)

Warnings and Precautions (34071-1)

WARNINGS: FOR EXTERNAL USE ONLY.

DO NOT INGEST.

Section 42229-5 (42229-5)

DRUG FACTS

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 50566-9 (50566-9)

Stop use and ask doctor if: Irritation, rash, or other allergic reaction occurs.

Section 50567-7 (50567-7)

When using this product: Do not use in

or near the eyes and mouth (oral mucosa). In

case of eye contact, flush eyes with water.

Section 50570-1 (50570-1)

Do not use if: you are allergic or sensitive to any of the listed ingredients.

Section 51727-6 (51727-6)

Inactive ingredients: Water (aqua), Lauryl Glucoside, Propylene Glycol, Cocamidopropyl Betaine, PPG-2 Hydroxyethyl Cocamide, Xanthan Gum, Citric Acid, Tetrasodium EDTA, Bis-Diglyceryl Polyacyladipate-2

Section 55105-1 (55105-1)

Purpose: Antiseptic

Section 55106-9 (55106-9)

Active ingredient: Chloroxylenol 3%

Section 60561-8 (60561-8)

Other information: Avoid freezing. Store between 4˚C and 30˚C (40˚F and 86˚F)

Principal Display Package Labeling

RECOVERY

ANTISEPTIC

SKIN PREP

VEGAN-FRIENDLY

FREE OF ALCOHOL, PARABENS,

FRAGRANCES & DYES

30 FL. OZ. (900 mL)

NDC: 49436-377-30

recoveryaftercare.com

@recoveryaftercare

Distributed by

Recovery Aftercare, Inc.

Hanover, MD 21076

Made in Canada

©Recovery Aftercare, Inc. 2020



res


Advanced Ingredient Data


Raw Label Data

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