NITELA CLEAN HAND SANITIZER- alcohol gel

nitela clean hand sanitizer by

Drug Labeling and Warnings

nitela clean hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Skin n Skin Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol

INACTIVE INGREDIENT

water, glycerin, carbomers, trolamine, aloe extract (09), parsley extract, orange oil, limonene

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

WARNINGS

For external use only. Flammable. Keep away from heat or flame.

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse 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.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NITELA CLEAN HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74674-0005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	350 mL  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
PARSLEY (UNII: 58FMD0Q0EV)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE (UNII: V5VD430YW9)
ORANGE OIL (UNII: AKN3KSD11B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74674-0005-1	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/10/2020

Labeler - Skin n Skin Co., Ltd. (631090037)

Registrant - Skin n Skin Co., Ltd. (631090037)

Establishment
Name	Address	ID/FEI	Business Operations
Skin n Skin Co., Ltd.		631090037	manufacture(74674-0005) , label(74674-0005) , pack(74674-0005)