Hand Sanitizing Gel Orange Oil

Hand Sanitizing by

Drug Labeling and Warnings

Hand Sanitizing by is a Otc medication manufactured, distributed, or labeled by PureTek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZING- alcohol liquid 
PureTek Corporation

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.

----------

Hand Sanitizing Gel Orange Oil

Active Ingredient

Alcohol 62% (v/v)

Purpose

Anti-Bacterial

Uses

■ Hand sanitizer to help reduce bacteria on the skin

Warnings

■ Flammable. Keep away from fire or flame.

When using this product

■ do not use in or near eyes. In case of contact, rinse eyes throughly with water

Stop use and ask a doctor if

■ irritation or redness develop and last 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

■ Dispense and rub onto hands until dry. Do not rinse off.

■ Children under 6 years of age should use this product under supervision.

■ repeat as necessary

Other information

■ Do not store above 110°F (43°C)

Inactive ingredients

Aloe Barbadensis (aloe vera) Leaf Juice, Aminomethyl Propanol, Butyrospermum Parkii (Shea)
Butter, Carbomer, Glycerin, Isopropyl Myristate, Citrus aurantium dulcis (Orange) Peel Oil, Panthenol, Water (Aqua).

GenRx Hand Sanitizing Gel

HAND SANITIZING 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59088-370
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)
CITRUS AURANTIUM FRUIT RIND (UNII: 055456JHI7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59088-370-31	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020	06/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/15/2020	06/29/2020

Labeler - PureTek Corporation (785961046)

Establishment
Name	Address	ID/FEI	Business Operations
PureTek Corporation		785961046	manufacture(59088-370) , label(59088-370)

Revised: 6/2020

Document Id: a9419276-8767-a801-e053-2995a90a3a9e

34390-5

Set id: a5b3d03c-fe78-5955-e053-2995a90a9784

Version: 2

Effective Time: 20200629