HANDS FIRST 4 IN 1- benzalkonium chloride, allantoin solution 
Avadim II LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient(s)

Allantoin 0.5%
Benzalkonium Chloride 0.13%

Indications & Usage

Skin Protectant

Antimicrobial

Use(s)

For handwashing to decrease bacteria on the skin

For temporary protection of minor cuts, scrapes, burns, and chapped or cracked skin

Directions

Use as needed

Remove cap and pump foam into palm of hand.

Rub foam onto hands

Allow to air dry

Purpose

Skin Protectant

Antimicrobial

Use(s)

For handwashing to decrease bacteria on the skin

For temporary protection of minor cuts, scrapes, burns, and chapped or cracked skin

Directions

Use as needed

Remove cap and pump foam into palm of hand.

Rub foam onto hands

Allow to air dry

Warnings

For external use only
Keep out of the reach of children
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

Dosage & Administration

Dosage & Administration

Keep out of the reach of children

Keep out of the reach of children

Stop use and ask a doctor if condition worsens or symptoms last more than seven days.

Inactive ingredients

Purified Water, tego-betaine, aloe vera, dimethicone, *collodial silver, glycolic acid, potassium hydroxide, EDTA, phenoxyethanol, isobutyl paraben, propyl paraben, ethyl paraben, butyl paraben, methyl paraben

*Preservative only .1%

Package Label - Principal Display Panel

000 L (000 mL) NDC: 00000-000-00

image description

HANDS FIRST  4 IN 1
benzalkonium chloride, allantoin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51098-742
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.5 g  in 100 L
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN1.3 g  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51098-742-020.360 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/201008/01/2021
2NDC:51098-742-010.050 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/201008/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/201008/01/2021
Labeler - Avadim II LLC (962520412)
Establishment
NameAddressID/FEIBusiness Operations
Avadim II LLC962520412manufacture(51098-742)

Revised: 8/2021
 
Avadim II LLC