HAND SANITIZER WATERMELON- alcohol gel
Lemontree ICS

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, Watermelon

Drug Facts

Active ingredient

Ethyl alcohol 75%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin

Warnings

For external use only

Flammable, keep away from fire or flame

Do not use

in the eyes

Stop use and ask a doctor if

irritation and redness develop
condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping

Other information

Store between 15-30°C (59-86°F)
Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

Carbomer, Denatonium Benzoate, FD&C Blue No. 1, FD&C Yellow No. 5, Fragrance, Glycerin, Propylene Glycol, Sodium Hydroxide, Water.

Questions?

CHEMTREC(contracted consultant):1-800-424-9300

Package Labeling:

Bottle16

HAND SANITIZER WATERMELON
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79834-115
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:79834-115-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/15/2020

Labeler - Lemontree ICS (117589151)