ULTRA DEFENSE SANI SMART TROPICAL SUNRISE HAND SANITIZER- alcohol denat. 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 Tropical Sunrise Hand Sanitizer

Active ingredient

Alcohol Denat. 62%

Purpose

Antiseptic

Use

Use for hand-washing to decrease bacteria on the skin, only when water it not available.

Warnings

For external use only. Flammable, keep away from fire and flames.

When using this product

Do not get into eyes.

If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

If irritation and 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.

Other information

Store at 68 to 77F (20-25C)

Do not store above 110F (43C)

You may report a serious adverse reaction to this product to Report Reaction, LLC, PO Box 22, Plainsboro, NJ 08536

Inactive ingredients

Water,

Glycerin,

Acrylates/C10-30 Alkyl Acrylate Crosspolymer,

Fragrance,

Aloe Barbadensis Leaf Extract,

Polysorbate 20,

Sodium Hydroxide,

Red 33

Label

Label

ULTRA DEFENSE SANI SMART TROPICAL SUNRISE HAND SANITIZER 
alcohol denat. gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51522-054
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51522-054-01236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/05/2020
Labeler - Gold Orient International Limited (679905914)
Establishment
NameAddressID/FEIBusiness Operations
Gold Orient International Limited679905914manufacture(51522-054)

Revised: 8/2020
Document Id: ac1c543a-eb8e-46c5-e053-2a95a90af681
Set id: ac1c543a-eb8d-46c5-e053-2a95a90af681
Version: 1
Effective Time: 20200805
 
Gold Orient International Limited