Hand Sanitizer Moisturizing Gel 500mL

RACLEN ANTI-BACTERIAL HAND SANITIZER NON-WASHABLE by

Drug Labeling and Warnings

RACLEN ANTI-BACTERIAL HAND SANITIZER NON-WASHABLE by is a Otc medication manufactured, distributed, or labeled by Lafang China Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RACLEN ANTI-BACTERIAL HAND SANITIZER NON-WASHABLE- alcohol gel 
Lafang China Co.,Ltd

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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Hand Sanitizer Moisturizing Gel 500mL

Active Ingredient(s)

Ethanol 75% v/v. Purpose: Antiseptic

Inactive ingredients

Water, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Directions for Use

Take a thumbnail size drop on your palm and rub your hands together covering all surfaces of both hands, including between your fingers and up around your fingertips and nails. Rub hands together until completely dry.

Warnings

Keep away from a naked flame, source of heat, open live electric wire, etc.

Do not use

Not for injection and do not use in body cavities.

Keep out of reach of children.

If irritation occurs, wash affected area and discontunue use.

Avoid contact with eyes. Do not swallow.

Other information

• Store in a cool dry place.

Use Hand sanitizer to effective at eliminating 99.9% of many common harmful germs and bacteria.

Antiseptic

Package Label - Principal Display Panel

500 mL NDC: 74612-001-01

RACLEN ANTI-BACTERIAL HAND SANITIZER NON-WASHABLE 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74612-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74612-001-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/03/2020	04/07/2020

Labeler - Lafang China Co.,Ltd (528008256)

Establishment
Name	Address	ID/FEI	Business Operations
Lafang China Co.,Ltd		528008256	manufacture(74612-001)

Revised: 4/2020

Document Id: a2bd4261-7ea0-f95d-e053-2a95a90a21a1

34390-5

Set id: a25c84ff-788d-580d-e053-2995a90a6fbb

Version: 2

Effective Time: 20200407

 

Lafang China Co.,Ltd