HAND SANITIZER- antibacterial hand sanitizer gel
JFL Enterprises, 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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Green Apple - Antibacterial Hand Sanitizer

Active Ingredient - Ethyl Alcohol 62%.....Antiseptic

Purpose - Antiseptic

Use

To decrease bacteria on hands

Warnings

For external use only

Flammable, keep away from fire or flame

Keep out of reach of children

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

WHEN USING SECTION

Keep out of eyes,In case of contact flush eyes with water.

Avoid contact with broken skin.

Discontinue use if irritation or redness develop.

Directions

Rub hands thoroughly with product and allow to dry.

Inactive Ingredients

Water, Glycerin, Carbomer, Fragrance, Propylene Glycol, Carbomer Aminomethyl Propanol,Yellow No 5, Blue No 1

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HAND SANITIZER
antibacterial hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71246-0012
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	620 mL in 1000 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71246-0012-6	59.14 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/13/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/13/2020

Labeler - JFL Enterprises, Inc. (010967011)