Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 2c2abaa8-c152-470b-a4d9-5056815a1987
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
Phenoxyethanol Water Decyl Glucoside Potassium Sorbate Sodium Benzoate Edetate Disodium Anhydrous Citric Acid Monohydrate Aloe Vera Leaf .alpha.-tocopherol Acetate Bergamot Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-15

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

​Do not use if you are allergic to any of these ingredients

Directions
  • adults and childrens 2 years and over: apply to hands, allow to dry without wiping
  • children under 2 years: ask a doctor before use

To Dispense: ​Peel back front label slowly. Remove Wipes

To Reseal: ​Firmly rub thumb over label. Dispose of wipe in thrash. Do not flush

Active Ingredient

Benzalkonium chloride.........0.13%

Other Information
  • Store below 95°F (35°C)
  • keep closed tightly
  • may discolor certain fabrics or surfaces
Inactive Ingredients

Purified Water, Phenoxyethanol, Decyl Glucoside, Potassium Sorbate, Sodium Benzoate, Disodium EDTA, Citric Acid, Aloe Barbadensis (Aloe) Leaf Extract, Tocopheryl Acetate, Organic Citrus Auranium Bergamia Fruit Oil.

Principal Display Panel

NDC: 77677-013-20

SONO ®​ HEALTHCARE

MADE IN USA

HAND SANITIZING WIPES

WITH MOISTURIZER AND BERGAMOT ESSENTIAL OIL

Kills 99.9% of most common germs

20 Wipes

New Contents: 20 pre-moistened sanitizing wipes, 7X8

NDC: 77677-013-01

SONO

HAND SANITIZING WIPES

Aloe and Bergamont Essental Oils

MADE IN USA

with globally sourced materials

One Large 7''x 8" Wipes

Kills 99.9% of Germs

When Using This Product

Avoid contact with eyes. In case of eye 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 a 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

​Do not use if you are allergic to any of these ingredients

Directions
  • adults and childrens 2 years and over: apply to hands, allow to dry without wiping
  • children under 2 years: ask a doctor before use

To Dispense: ​Peel back front label slowly. Remove Wipes

To Reseal: ​Firmly rub thumb over label. Dispose of wipe in thrash. Do not flush

Active Ingredient (Active ingredient)

Benzalkonium chloride.........0.13%

Other Information (Other information)
  • Store below 95°F (35°C)
  • keep closed tightly
  • may discolor certain fabrics or surfaces
Inactive Ingredients (Inactive ingredients)

Purified Water, Phenoxyethanol, Decyl Glucoside, Potassium Sorbate, Sodium Benzoate, Disodium EDTA, Citric Acid, Aloe Barbadensis (Aloe) Leaf Extract, Tocopheryl Acetate, Organic Citrus Auranium Bergamia Fruit Oil.

Principal Display Panel

NDC: 77677-013-20

SONO ®​ HEALTHCARE

MADE IN USA

HAND SANITIZING WIPES

WITH MOISTURIZER AND BERGAMOT ESSENTIAL OIL

Kills 99.9% of most common germs

20 Wipes

New Contents: 20 pre-moistened sanitizing wipes, 7X8

NDC: 77677-013-01

SONO

HAND SANITIZING WIPES

Aloe and Bergamont Essental Oils

MADE IN USA

with globally sourced materials

One Large 7''x 8" Wipes

Kills 99.9% of Germs

When Using This Product (When using this product)

Avoid contact with eyes. In case of eye 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 a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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