ULTRA DEFENSE SANI SMART 15 PK HAND SANITIZER- alcohol gel

Ultra Defense Sani Smart 15 PK Hand Sanitizer by

Drug Labeling and Warnings

Ultra Defense Sani Smart 15 PK Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Gold Orient International Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol Denat. 62%

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to decrease bacteria on the skin, only when water is not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

WHEN USING

• do not get into eyes
• if contact occurs, rinse eyes thoroughly with water

STOP USE

Stop use and ask a doctor if irritation or rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Wet hands thorough;y with product and allow to dry without wiping

Other information

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

Inactive ingredients

glycerin, water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Polysorbate 20, Sodium Hydroxide

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

ULTRA DEFENSE SANI SMART 15 PK HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51522-005
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51522-005-01	1 in 1 JAR	03/30/2020
1		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Gold Orient International Limited (679905914)

Establishment
Name	Address	ID/FEI	Business Operations
Gold Orient International Limited		679905914	manufacture(51522-005)