ASSURED ALOE- ethyl alcohol gel 
China Ningbo Shangge Cosmetic Technology Corp.

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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Assured Aloe

Active Ingredient Purpose

Ethyl Alcohol 70.0% v/v..................... Antimicrobial

Uses

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Assured

Instant Hand Sanitizer

Kills 99% of germs!

Aloe Vera & Moisturizers

Compare to Active Ingredients in Purell® Hand Sanitizer*

Special Value 25% more free

10 fl oz / 295 ml

*This product is not manufactured or distributed by Gojo Industries Inc, distributor of the registered trademark Purell

Directions

Warnings

For external use only.

Flammable, keep away from heat and flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Inactive Ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, fd&c blue no. 1, fd&c yellow no. 5.

label

ASSURED ALOE 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-095
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58503-095-01295 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/01/2017
Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-095)

Revised: 9/2019
Document Id: 92d44bd6-beac-6134-e053-2995a90ad120
Set id: 4db19cf4-aff0-3b0d-e054-00144ff88e88
Version: 2
Effective Time: 20190918
 
China Ningbo Shangge Cosmetic Technology Corp.