ULTRA DEFENSE SANI SMART HAND SANITIZER- alcohol gel

Ultra Defense Sani Smart Hand Sanitizer by

Drug Labeling and Warnings

Ultra Defense Sani Smart 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]

INDICATIONS & USAGE

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

Drug Facts Active Ingredients

Ethyl Alcohol 65%

Purpose

Antiseptic

DOSAGE & ADMINISTRATION

• 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

Keep out of reach of children.

WHEN USING

When using this product

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

STOP USE

Stop us and ask a doctor if

• irritation and redness develop

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 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(51522-001)