HAND SANITIZER- ethyl alcohol gel
Ultra Distributors Inc

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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HAND SANITIZER Princess

Active ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

to decrease bacteria on the skin that could cause disease
recommended for repeated use

Warnings

For external use only: hands

Flammable. Keep away from fire or flame

When using this product

keep out of eyes. In case of contact with eyes, flush thoroughly with water.
avoid contact with broken skin.
do not inhale or ingest.

Stop use and ask a doctor if

irritation or redness develops.
condition persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a poison control center(1-800-222-1222)right away.

Directions

wet hands thoroughly with product and allow to dry without wiping.
for children under 6 , use only under adult supervision.
not recommended for infants .

Other information

do not store above 105°F
may discolor some fabics
harmful to wood finished and plastics

Inactive ingredients

water, glycerin, propylene glycol, acrylates/C10-C30 alkyl acrylate crosspolymer, triethanolamine, aloe barbadensis leaf juice, maltodextrin

image of bottle label

HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78495-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:78495-001-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/04/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/04/2020

Labeler - Ultra Distributors Inc (007160073)