SURE SAFE HAND SANITIZER- alcohol gel

Sure Safe Hand Sanitizer by

Drug Labeling and Warnings

Sure Safe Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Jab Holdings LLC, GUANGZHOU ORCHARD AROMATHERAPY & SKIN CARE CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

Active Ingredient:

Ethyl Alcohol 75%

Purpose:

Antiseptic

USES:

For hand sanitizing to decrease bacteria on the skin
Recommended for repeated use

WARNINGS:

For external use only

When using this product:.

avoid contact with eyes. In case of eye contact, flush eyes with water

Stop use and ask a doctor if:

irritation or redness develops, or if 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:

Squeeze appropriate amount of sanitizer onto hands and rub together until dry. Use as needed. For children under 6, use with adult supervision. Not recommended for infants.

INACTIVE INGREDIENTS:

Water, Aloe Barnadensis Leaf Extract, Acrylates/C10-30 alkyl Acrylate Crosspolymer, Tetrahydroxypropyl Ethylenediamine

Package Labeling: 120ml

Package Labeling: 500ml

INGREDIENTS AND APPEARANCE

SURE SAFE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78111-010
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETOL (UNII: Q4R969U9FR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78111-010-00	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020
2	NDC: 78111-010-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/14/2020

Labeler - Jab Holdings LLC (117502199)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGZHOU ORCHARD AROMATHERAPY & SKIN CARE CO.,LTD		542355899	manufacture(78111-010) , label(78111-010)