Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID c344f26c-d043-4f9f-857e-4763d424c411
Route
TOPICAL
Published
Effective Date 2021-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Decyl Glucoside Aloe Vera Leaf Edetate Disodium Anhydrous Citric Acid Monohydrate Phenoxyethanol Potassium Sorbate Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

Benzalkonium chloride 0.13%

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Benzalkonium chloride 0.13%

Uses
  • For hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use
Warnings

For external use only

Directions
  • adults and children 2 years and over: apply to hands; allow to dry without wiping.
  • children under 2 years: ask a doctor before use.
Do Not Use

if you are allergic to any of these ingredients

Active Ingredient

Benzalkonium chloride 0.13%

Other Information
  • store below 95°F (35°C).
  • may discolor certain fabrics or surfaces.
Inactive Ingredients

Water, Decyl Glucoside, Aloe Barbadensis (Aloe) Leaf Extract, Disodium EDTA, Citric Acid, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate.

Principal Display Panel

NDC 73725-013-60

Nature's Baby

alcohol-free hand sanitizing wipes

fragrance free

97.5% purified water • softer & more absorbent biodegradable • decomposable

no chlorine phthalates, parabens, or sulfates moisturizing and hypo-allergenic

kills 99.9% of most common harmful germs & bacteria

Individually-wrapped packaging makes it convenient and easy to carry in purse, during travels and elsewhere outside of your home.

Our wipes are formulated to be gentle on skin and do not contain fragrance, dye, triclosan, parabens or phthalates

The 60-count individual wraps fit anywhere, making it convenient to take with you throughout the day while you are on-the-go.

Distributed by Nature's Organics, LLC 1560-1 Newbury Rd., #284

Newbury Park, CA 91320

www.naturesbaby.com

Follow us @ twitter.com/ntrsbabyorganic Like us @ facebook.com

Made in USa

60 Individually Packaged Wipes • 8 in x 6 in (20.32cm x 15.24 cm)

When Using This Product

avoid contact with eyes. In case of contact, flush eyes with water.

Stop Use and Ask A Doctor

If irritation or redness develops, or if condition persists for more than 72 hours.

Keep Out of Reach of Children

If swallowed, get medical help or contact Poison Control Center right away.


Structured Label Content

Uses
  • For hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use
Purpose

Antimicrobial

Warnings

For external use only

Directions
  • adults and children 2 years and over: apply to hands; allow to dry without wiping.
  • children under 2 years: ask a doctor before use.
Do Not Use (Do not use)

if you are allergic to any of these ingredients

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13%

Other Information (Other information)
  • store below 95°F (35°C).
  • may discolor certain fabrics or surfaces.
Inactive Ingredients (Inactive ingredients)

Water, Decyl Glucoside, Aloe Barbadensis (Aloe) Leaf Extract, Disodium EDTA, Citric Acid, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate.

Principal Display Panel

NDC 73725-013-60

Nature's Baby

alcohol-free hand sanitizing wipes

fragrance free

97.5% purified water • softer & more absorbent biodegradable • decomposable

no chlorine phthalates, parabens, or sulfates moisturizing and hypo-allergenic

kills 99.9% of most common harmful germs & bacteria

Individually-wrapped packaging makes it convenient and easy to carry in purse, during travels and elsewhere outside of your home.

Our wipes are formulated to be gentle on skin and do not contain fragrance, dye, triclosan, parabens or phthalates

The 60-count individual wraps fit anywhere, making it convenient to take with you throughout the day while you are on-the-go.

Distributed by Nature's Organics, LLC 1560-1 Newbury Rd., #284

Newbury Park, CA 91320

www.naturesbaby.com

Follow us @ twitter.com/ntrsbabyorganic Like us @ facebook.com

Made in USa

60 Individually Packaged Wipes • 8 in x 6 in (20.32cm x 15.24 cm)

When Using This Product (When using this product)

avoid contact with eyes. In case of contact, flush eyes with water.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

If irritation or redness develops, or if condition persists for more than 72 hours.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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