ULTRA DEFENSE SANI SMART 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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Ultra Defense Sani Smart Hand Sanitizer

for hand washing to decrease bacteria on the skin only when water is not available.

Drug Facts
Active Ingredients

Ethyl Alcohol 65%

Purpose

Antiseptic

wet hands thoroughly with product and allow to dry without wiping

Inactive Ingredients:

Water(Aqua), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Sodium Hydroxide, Fragrance (Parfum)

Warning

For External Use Only.
Flammable, keep away from fire and flames

Keep out of reach of children.

When using this product

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

Stop us and ask a doctor if

irritation and redness develop

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

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ULTRA DEFENSE SANI SMART HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51522-001
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
WATER (UNII: 059QF0KO0R)	33 mL in 100 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51522-001-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
2	NDC:51522-001-02	59 mL in 1 TUBE; Type 0: Not a Combination Product	03/30/2020
3	NDC:51522-001-03	225 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC:51522-001-04	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020

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(51522-001)

Ultra Defense Sani Smart Hand Sanitizer

Drug Facts Active Ingredients

Purpose

Inactive Ingredients:

Warning

Drug Facts
Active Ingredients