ULTRA DEFENSE SANI SMART HAND SANITIZER BOTANICAL SCENT WITH VITAMIN E by Ouya Cosmetics Co., Ltd of Yiwu

ULTRA DEFENSE SANI SMART HAND SANITIZER BOTANICAL SCENT WITH VITAMIN E by

Drug Labeling and Warnings

ULTRA DEFENSE SANI SMART HAND SANITIZER BOTANICAL SCENT WITH VITAMIN E 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]

ULTRA DEFENSE SANI SMART HAND SANITIZER BOTANICAL SCENT WITH VITAMIN E- alcohol solution 
Ouya Cosmetics Co., Ltd of Yiwu

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 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 flames

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

Stop use and ask a doctor if irritation or redness develop

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, denatonium benzoate

ULTRA DEFENSE SANI SMART HAND SANITIZER BOTANICAL SCENT WITH VITAMIN E 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54699-007
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 940 (UNII: 4Q93RCW27E)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54699-007-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020
2	NDC: 54699-007-02	88 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020
3	NDC: 54699-007-03	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/15/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
Ouya Cosmetics Co., Ltd of Yiwu		546464926	manufacture(54699-007)

Revised: 7/2020

Document Id: aa873dde-72bc-5914-e053-2995a90a30db

34390-5

Set id: f3cfb85f-fdc8-404a-8baf-4f24869a6f28

Version: 1

Effective Time: 20200715