Label: HANDS FIRST 4 IN 1- benzalkonium chloride, allantoin solution
- Category: HUMAN OTC DRUG LABEL
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.
Updated July 13, 2010
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
Benzalkonium Chloride 0.13%
For handwashing to decrease bacteria on the skin
For temporary protection of minor cuts, scrapes, burns, and chapped or cracked skin
Use as needed
Remove cap and pump foam into palm of hand.
Rub foam onto hands
Allow to air dry
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
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
HANDS FIRST 4 IN 1
benzalkonium chloride, allantoin solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51098-742 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin 5 g in 1000 mL Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride 1.3 mL in 1000 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51098-742-02 360 mL in 1 BOTTLE, PLASTIC 2 NDC:51098-742-01 50 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/01/2010 Labeler - Avadim II LLC (962520412)