Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 4df71478-5405-4980-8112-59d5f841627c
Route
TOPICAL
Published
Effective Date 2015-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.26 g)
Inactive Ingredients
Water Alcohol Phenoxyethanol Decyl Glucoside Potassium Sorbate Sodium Benzoate Edetate Disodium Citric Acid Monohydrate Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-06-18

Description

Benzalkonium Chloride  0.13%

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride  0.13%

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

Warnings

For external use only.

Directions

For  40 Count wipes:





  • Take wipe and rub thoroughly over all surfaces of both hands.
  • Rub hands together briskly to dry and allow to air dry.
  • Dispose of wipe in trash.
  • Do not flush.


For 20 Count wipes:

            

            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:Peel back front label slowly. Remove Wipes.
  • To Reseal: Firmly run thumb over the label. Dispose of wipe in trash. 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 F (35 C)
  • Keep closed tightly.
  • May discolor certain fabrics or surfaces.

Inactive Ingredients

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



Principal Display Panel

Sanitex®

Antibacterial

HAND WIPES

Kills 99.9% of Germs

Enriched with Aloe

CITRUS SCENT

40 wipes| 5.6 inch x 7.5 inch (14.2 cm x 19.05 cm)

Sanitex®

Antibacterial

HAND WIPES

Kills 99.9% of Germs

Enriched with Aloe

CITRUS SCENT

20 wipes| 5.6 inch x 7.5 inch (14.2 cm x 19.05 cm)









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 the Reach Children.

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




Structured Label Content

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

Purpose

Antimicrobial

Warnings

For external use only.

Directions

For  40 Count wipes:





  • Take wipe and rub thoroughly over all surfaces of both hands.
  • Rub hands together briskly to dry and allow to air dry.
  • Dispose of wipe in trash.
  • Do not flush.


For 20 Count wipes:

            

            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:Peel back front label slowly. Remove Wipes.
  • To Reseal: Firmly run thumb over the label. Dispose of wipe in trash. Do not flush.

Do Not Use If (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)
  • Keep closed tightly.
  • May discolor certain fabrics or surfaces.

Inactive Ingredients (Inactive ingredients)

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



Principal Display Panel

Sanitex®

Antibacterial

HAND WIPES

Kills 99.9% of Germs

Enriched with Aloe

CITRUS SCENT

40 wipes| 5.6 inch x 7.5 inch (14.2 cm x 19.05 cm)

Sanitex®

Antibacterial

HAND WIPES

Kills 99.9% of Germs

Enriched with Aloe

CITRUS SCENT

20 wipes| 5.6 inch x 7.5 inch (14.2 cm x 19.05 cm)









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 the Reach Children. (Keep out of the reach children.)

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




Advanced Ingredient Data


Raw Label Data

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