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

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ULTRA DEFENSE SANI SMART HAND SANITIZER BOTANICAL SCENT WITH VITAMIN E 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54699-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL69 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54699-007-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
2NDC: 54699-007-0288 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
3NDC: 54699-007-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/15/2020
Labeler - Ouya Cosmetics Co., Ltd of Yiwu (546464926)
Establishment
NameAddressID/FEIBusiness Operations
Ouya Cosmetics Co., Ltd of Yiwu546464926manufacture(54699-007)

Revised: 7/2020