ULTRA DEFENSE SANI SMART 15 PK HAND SANITIZER- alcohol gel
Gold Orient International Limited

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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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

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

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

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

label

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - Gold Orient International Limited (679905914)

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