Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID d64e5183-07b2-4254-967f-289b52a9ff8e
Route
TOPICAL
Published
Effective Date 2021-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Cocamidopropyl Betaine Allantoin Glycolic Acid Dimethicone Aloe Vera Leaf Silver English Lavender Oil Edetate Sodium Phenoxyethanol Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-05-07

Description

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%

Use
  • For handwashing to decrease bacteria on the skin
  • For temporary protection of minor cuts, scrapes, burns and chapped or cracked skin
Warning
  • For external use only.
  • Keep out of the reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.
  • Do not use in the eyes.
  • Do not use on deep or puncture wounds, animal bites or serious burns.
  • Extended use may increase risk of sunburn.
Direction
  • Uses as needed.
  • Remove cap and pump foam into palm of hands.
  • Rub foam onto hands.
  • Allow to air dry.
Questions?

Call 1-800-603-0589 between 9am and 5pm (EST) Monday through Friday or visit www.handsfirst.com

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information
  • save carton for full directions and warnings
  • store between 20 to 25oC (68 to 77oF)
Inactive Ingredients

water, cocamidopropyl betaine , allantoin, glycolic acid, dimethicone, aloe vera leaf, lavender extract, colloidal silver, tetrasodium EDTA, phenoxyethanol, ethylhexyl glycerine.

Stop Use and Ask A Doctor If:
  • symptoms worsen, last for more than seven days, or new symptoms occur at any time
Package Label.principal Display Panel

Hands First

4 in 1 action

Alcohol Free Foam

Hand Sanitizer

Doctor created and hospital tested

Sanitize anytime, anywhere

Temporarily protect minor cuts and scrapes

Hydrate your skin

Clean without water

Kills 99.99% of germs

6 fl oz (177mL)


Structured Label Content

Use
  • For handwashing to decrease bacteria on the skin
  • For temporary protection of minor cuts, scrapes, burns and chapped or cracked skin
Purpose

Antimicrobial

Warning
  • For external use only.
  • Keep out of the reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.
  • Do not use in the eyes.
  • Do not use on deep or puncture wounds, animal bites or serious burns.
  • Extended use may increase risk of sunburn.
Direction
  • Uses as needed.
  • Remove cap and pump foam into palm of hands.
  • Rub foam onto hands.
  • Allow to air dry.
Questions?

Call 1-800-603-0589 between 9am and 5pm (EST) Monday through Friday or visit www.handsfirst.com

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information (Other information)
  • save carton for full directions and warnings
  • store between 20 to 25oC (68 to 77oF)
Inactive Ingredients (Inactive ingredients)

water, cocamidopropyl betaine , allantoin, glycolic acid, dimethicone, aloe vera leaf, lavender extract, colloidal silver, tetrasodium EDTA, phenoxyethanol, ethylhexyl glycerine.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • symptoms worsen, last for more than seven days, or new symptoms occur at any time
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Hands First

4 in 1 action

Alcohol Free Foam

Hand Sanitizer

Doctor created and hospital tested

Sanitize anytime, anywhere

Temporarily protect minor cuts and scrapes

Hydrate your skin

Clean without water

Kills 99.99% of germs

6 fl oz (177mL)


Advanced Ingredient Data


Raw Label Data

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