Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 36611b25-c2e2-4e00-941a-3c693d0f5d8b
Route
TOPICAL
Published
Effective Date 2021-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-05-21

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
  • For surface sanitizing
Warnings

For external use only

Directions
  • Adults and Children 2 Years and Over. Apply to hands and face; Allow to dry without wiping.
  • Children Under 2 Years: Ask a doctor before use.

To Dispense:

  • DO NOT remove wipes roll from the heat sealed plastic bag.
  • DO NOT cut across the top of the entire bag.
  • Cut a “V” shaped opening on the top center of the bag.
  • Pull up the first wipe from the center of the roll.
  • Thread through the star shaped opening in the underside of the dispenser cover.
  • Secure the cover to the body.
  • To dispense, pull each sheet up and slightly to the side.

Dispose of wipes in thrash. Do not flush

Do Not Use If

you are allergic to any of these ingredients

Active Ingredient

Benzalkonium chloride 0.13%

Other Information
  • Store below 95 o​F (35 oC).
  • Keep closed tightly.
  • May discolor certain fabric or surfaces
Inactive Ingredients

Water, SD Alcohol 40, Phenoxyethanol, Decyl Glucoside, Potassium Sorbate, Sodium Benzoate, Disodium EDTA,  Citric Acid, Aloe Barbadensis  (Aloe)  Leaf Extract, Fragrance.

Principal Display Panel

NDC:70691-900-13

Glaro Incorporated

Antibacterial Wipes For Sanitizing Surfaces and Hands

Wipes per roll: 900

Wipe size: 8” x 6”

Do Not Flush

Glaro Incorporated 735 Calebs Path Hauppauge, NY 11788-4201

www.Glaro.com

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 immediately.


Structured Label Content

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

Antimicrobial

Warnings

For external use only

Directions
  • Adults and Children 2 Years and Over. Apply to hands and face; Allow to dry without wiping.
  • Children Under 2 Years: Ask a doctor before use.

To Dispense:

  • DO NOT remove wipes roll from the heat sealed plastic bag.
  • DO NOT cut across the top of the entire bag.
  • Cut a “V” shaped opening on the top center of the bag.
  • Pull up the first wipe from the center of the roll.
  • Thread through the star shaped opening in the underside of the dispenser cover.
  • Secure the cover to the body.
  • To dispense, pull each sheet up and slightly to the side.

Dispose of wipes in thrash. Do not flush

Do Not Use If (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 o​F (35 oC).
  • Keep closed tightly.
  • May discolor certain fabric or surfaces
Inactive Ingredients (Inactive ingredients)

Water, SD Alcohol 40, Phenoxyethanol, Decyl Glucoside, Potassium Sorbate, Sodium Benzoate, Disodium EDTA,  Citric Acid, Aloe Barbadensis  (Aloe)  Leaf Extract, Fragrance.

Principal Display Panel

NDC:70691-900-13

Glaro Incorporated

Antibacterial Wipes For Sanitizing Surfaces and Hands

Wipes per roll: 900

Wipe size: 8” x 6”

Do Not Flush

Glaro Incorporated 735 Calebs Path Hauppauge, NY 11788-4201

www.Glaro.com

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 immediately.


Advanced Ingredient Data


Raw Label Data

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