HAND SANITIZER ORANGE- alcohol swab
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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ANTIBACTERIAL WET WIPES

Active ingredient

Alcohol 65%

Purpose

Antiseptic Hand Sanitizer

Use

to decrease bacteria on the skin

Warnings

Keep out of reach of children

if swallowed

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

Directions

Liberally spray on skin and gently massage until absorbed

Inactive Ingredient

Carbomer, Glycerin, Jojoba Particles, Pigment Red 14, Pigment Yellow 4, Propylene Glycol, Triethanolamine, Water, Orange Extract

HAND SANITIZER (ALCOHOL) SWAB

HAND SANITIZER ORANGE
alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71246-3013
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
TROLAMINE (UNII: 9O3K93S3TK)
PIGMENT RED 7 (UNII: 5Z5A89AQ44)
PIGMENT YELLOW 3 (UNII: L885GOC9B6)
JOJOBA ACID (UNII: MO7HV04S9Y)
ORANGE (UNII: 5EVU04N5QU)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71246-3013-1	30 mL in 1 POUCH; Type 0: Not a Combination Product	02/02/2017	06/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/01/2017	06/30/2020

Labeler - JFL ENTERPRISES, INC (010967011)

Registrant - JFL ENTERPRISES, INC (010967011)

Name	Address	ID/FEI	Business Operations
Establishment
Dongguang Shuoguo Silicone Products Co., Ltd.		544426629	manufacture(71246-3013)

Revised: 6/2020

Document Id: a7e9636b-37c5-64d3-e053-2995a90ab0ce

Set id: ee909b34-1d43-427f-8bfd-ea8dbff6c163

Version: 2

Effective Time: 20200612

JFL ENTERPRISES, INC