drug facts

drug facts
SPL v8
SPL
SPL Set ID 48907146-ca66-46e1-928b-a8f968a6bff8
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
alcohol 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 2015-06-17

Purpose

Antimicrobial

Description

Benzalkonium Chloride  0.13%


Medication Information

Warnings

For external use only.

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

Purpose

Antimicrobial

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.

  • To dispense: Peel back front label slowly. Remove wipes.
  • To reseal: Firmly rub thumb over label.

Dispose of wipe in trash. Do not flush.

For single wipe sachet

  • Take wipe and rub thoroughly over all surfaces of both hands. Wet hands thoroughly with wipe.
  • Rub hands together briskly to dry without wiping.
  • Dispose of wipe
  • Do not flush
Other Information
  • Store below 95 F (35 C)
  • Keep closed tightly.
  • May discolor certain fabrics or surfaces.

For single sachet

store in a cool dry place

Inactive Ingredients

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

Description

Benzalkonium Chloride  0.13%

Principal Display Panel

NDC 53118-002-01

Sanitex ®

Antibacterial

HAND WIPES

Kills 99.9% of Germs

Enriched with Aloe

FRESH SCENT

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

NDC 53118-002-02

Sanitex ®

Antibacterial

HAND WIPES

Kills 99.9% of Germs

Enriched with Aloe

FRESH SCENT

20 wipes| 6 inch x 7 inch (15.2 cm x 17.8 cm)

NDC 53118-002-03

Sanitex ®

Antibacterial

HAND WIPE

Kills 99.9% of Germs

Enriched with Aloe

FRESH SCENT

1 Wipe | 6 inch X 8 inch (15.2 cm X 20.3 cm)

Do Not Use If

you are allergic to any of these ingredients.

Active Ingredient

Benzalkonium Chloride  0.13%

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

Warnings

For external use only.

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

Purpose

Antimicrobial

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.

  • To dispense: Peel back front label slowly. Remove wipes.
  • To reseal: Firmly rub thumb over label.

Dispose of wipe in trash. Do not flush.

For single wipe sachet

  • Take wipe and rub thoroughly over all surfaces of both hands. Wet hands thoroughly with wipe.
  • Rub hands together briskly to dry without wiping.
  • Dispose of wipe
  • Do not flush
Other Information
  • Store below 95 F (35 C)
  • Keep closed tightly.
  • May discolor certain fabrics or surfaces.

For single sachet

store in a cool dry place

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 53118-002-01

Sanitex ®

Antibacterial

HAND WIPES

Kills 99.9% of Germs

Enriched with Aloe

FRESH SCENT

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

NDC 53118-002-02

Sanitex ®

Antibacterial

HAND WIPES

Kills 99.9% of Germs

Enriched with Aloe

FRESH SCENT

20 wipes| 6 inch x 7 inch (15.2 cm x 17.8 cm)

NDC 53118-002-03

Sanitex ®

Antibacterial

HAND WIPE

Kills 99.9% of Germs

Enriched with Aloe

FRESH SCENT

1 Wipe | 6 inch X 8 inch (15.2 cm X 20.3 cm)

Do Not Use If (Do not use if)

you are allergic to any of these ingredients.

Active Ingredient

Benzalkonium Chloride  0.13%

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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