Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f4aa6e15-80f7-4de6-b27a-32cc9db659f7
Route
TOPICAL
Published
Effective Date 2021-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 mg)
Inactive Ingredients
Water Propylene Glycol Disodium Cocoamphodiacetate Phenoxyethanol Polysorbate 20 Aloe Vera Leaf Edetate Disodium Potassium Sorbate Citric Acid Monohydrate Sodium Citrate Allantoin .alpha.-tocopherol Acetate Iodopropynyl Butylcarbamate Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-03-01

Description

Benzalkonium Chloride 0.13% w/w

Purpose

Antiseptic skin cleanser


Medication Information

Purpose

Antiseptic skin cleanser

Description

Benzalkonium Chloride 0.13% w/w

Use

For cleansing of the body to decrease bacteria on the skin. Helps eliminate body odors

Section 50566-9

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours

Section 50570-1

Do not use on deep puncture wounds or serious burns

Warnings
  • For external use only
  • Flammable - Keep away from fire and flame
  • Avoid contact with eyes
  • If swallowed, get medical help or contact a Poison Control Center immediately.
Directions

For adults and children 2 years of age or older

  • WARM before use
  • Open packet and remove one wipe at a time
  • Firmly cleanse in order, each of the 7 areas, as depicted in the adjacent diagram
  • Discard each wipe after use
  • Do not flush in toilet

Children under 2 years of age, consult a doctor before use

Questions?

Call: 1-877-669-4648 Online: Nozin.com

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Other Information
  • Store in a cool, dry place between 15°C - 29°C (59°F - 84°F)
Inactive Ingredients

water, propylene glycol, disodium cocoamphodiacetate, phenoxyethanol, polysorbate 20, aloe barbadensis leaf juice, disodium EDTA, potassium sorbate, citric acid, sodium citrate, allantoin, tocopheryl acetate, iodopropynyl butylcarbamate

Instructions for Use of the Body Wipes:
  • Use each warmed wipe in the order below
  • Firmly massage skin with wipe to cleanse
  • If needed, use both sides of wipe at a site
  • Neck, shoulders, chest and abdomen
  • Right arm, hand, web spaces and axilla
  • Left arm, hand, web spaces and axilla
  • Groin and perineum
  • Right leg, right foot and web spaces
  • Left leg, left foot and web spaces
  • Neck, shoulders, back, buttocks and cleft
Principal Display Panel 24 Packets Case Label

Nozin ®

BODY BATH™

SKIN CLEANSING ANTISEPTIC WIPES

Rinse-Free

Hypoallergenic

Moisturizing

with Aloe

HELPS REDUCE RISK

OF INFECTION

  • pH-balanced
  • Pre-moistened
  • Fragrance-free
  • Extra thick

7 Wipes

8 x 8 inch each


Structured Label Content

Use

For cleansing of the body to decrease bacteria on the skin. Helps eliminate body odors

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours

Section 50570-1 (50570-1)

Do not use on deep puncture wounds or serious burns

Purpose

Antiseptic skin cleanser

Warnings
  • For external use only
  • Flammable - Keep away from fire and flame
  • Avoid contact with eyes
  • If swallowed, get medical help or contact a Poison Control Center immediately.
Directions

For adults and children 2 years of age or older

  • WARM before use
  • Open packet and remove one wipe at a time
  • Firmly cleanse in order, each of the 7 areas, as depicted in the adjacent diagram
  • Discard each wipe after use
  • Do not flush in toilet

Children under 2 years of age, consult a doctor before use

Questions?

Call: 1-877-669-4648 Online: Nozin.com

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13% w/w

Other Information
  • Store in a cool, dry place between 15°C - 29°C (59°F - 84°F)
Inactive Ingredients

water, propylene glycol, disodium cocoamphodiacetate, phenoxyethanol, polysorbate 20, aloe barbadensis leaf juice, disodium EDTA, potassium sorbate, citric acid, sodium citrate, allantoin, tocopheryl acetate, iodopropynyl butylcarbamate

Instructions for Use of the Body Wipes: (Instructions for use of the body wipes:)
  • Use each warmed wipe in the order below
  • Firmly massage skin with wipe to cleanse
  • If needed, use both sides of wipe at a site
  • Neck, shoulders, chest and abdomen
  • Right arm, hand, web spaces and axilla
  • Left arm, hand, web spaces and axilla
  • Groin and perineum
  • Right leg, right foot and web spaces
  • Left leg, left foot and web spaces
  • Neck, shoulders, back, buttocks and cleft
Principal Display Panel 24 Packets Case Label (Principal Display Panel - 24 Packets Case Label)

Nozin ®

BODY BATH™

SKIN CLEANSING ANTISEPTIC WIPES

Rinse-Free

Hypoallergenic

Moisturizing

with Aloe

HELPS REDUCE RISK

OF INFECTION

  • pH-balanced
  • Pre-moistened
  • Fragrance-free
  • Extra thick

7 Wipes

8 x 8 inch each


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)