CANDO ULTRA HAND SANITIZER- alcohol gel

CANDO Ultra Hand Sanitizer by

Drug Labeling and Warnings

CANDO Ultra Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Fabrication Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• In children less than 2 months of age
• On open skin wounds

WHEN USING

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

STOP USE

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

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

INGREDIENTS AND APPEARANCE

CANDO ULTRA HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51452-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51452-116-01	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/29/2020

Labeler - Fabrication Enterprises (070577218)