ULTRA DEFENSE SANI SMART HAND SANITIZER- alcohol solution

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 Ouya Cosmetics Co., Ltd of Yiwu. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

NA

Active Ingredient(s)

Alcohol Denat 69% v/v

Purpose

Antiseptic

Use

For hand washing to decrease reduce bacteria on the skin, only when water is not available

Warnings

For external use only.

Flammable. Keep away from fire and flame

WHEN USING

When using this product do not get into eyes. In contact occurs, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or 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.

Directions

• Wet hands thoroughly with product and allow to dry without wiping

Inactive ingredients

Water, propylene glycol, glycerin, carbomer, aloe barbadensis leaf extract, aminomethyl propanediol, tocopheryl acetate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA DEFENSE SANI SMART HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54699-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	69 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54699-003-01	88 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
2	NDC: 54699-003-02	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
3	NDC: 54699-003-03	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/19/2020

Labeler - Ouya Cosmetics Co., Ltd of Yiwu (546464926)

Establishment
Name	Address	ID/FEI	Business Operations
Ouya Cosmetics Co., Ltd of Yiwu		546464926	manufacture(54699-003)