CANDO ULTRA HAND SANITIZER- alcohol gel 
Fabrication Enterprises

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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CANDO Ultra
Hand Sanitizer

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

USES

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS

For external use only. Flammable.

Keep away from flame.

DO NOT USE

WHEN USING THE PRODUCT do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

STOP USE AND ASK A DOCTOR if irritation or rash occurs.

These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

●Put enough product in your palm to cover hands and rub hands briskly until dry.

●Children under 6 years of age should be supervised when using products.

OTHER INFORMATION

●Store below 104°F (40°C)

●Avoid freezing and excessive heat above 104°F (40°C)

●May discolor certain fabrics or surfaces

INACTIVE INGREDIENTS

Aloe Vera, Carbomer Interpolymer (type B), Glycerin, Lemon oil, Triethanolamine, Water (Aqua)

Package Label - Principal Display Panel

image of bottle label

CANDO ULTRA HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51452-116
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
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
LEMON OIL (UNII: I9GRO824LL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51452-116-01473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/29/2020
Labeler - Fabrication Enterprises (070577218)

Revised: 9/2020
Document Id: b06a3937-70bf-3ce0-e053-2995a90a2fa9
Set id: b06a362f-eebc-296f-e053-2995a90a8969
Version: 1
Effective Time: 20200928
 
Fabrication Enterprises