NORDIC WELLNESS VITAMIN C HAND SANITIZER- ethyl alcohol formulation liquid
Kala Corporation

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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Nordic Wellness™ Vitamin C Hand Sanitizer

Active Ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

Sanitizer to help reduce bacteria on skin. For use when soap and water not available.

Warnings

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

When using this product

Keep out of eyes. In case of contact, flush thoroughly with water.

Stop use and ask a doctor if

Keep out of reach of children

If swallowed get medical help or contact a poison control center right away.

Directions:

Apply on hands and rub until dry.

Other Information

Store between 15-30C(59-86F) - Avoid freezing and excess heat over 40C(104F)

Inactive Ingredients

Deionized Water, Glycerine, Orange Peel Extract, Fragrance Oil

Nordic Wellness™ Vitamin C Hand Sanitizer

Nordic Wellness™ Vitamin C Hand Sanitizer Label

NORDIC WELLNESS VITAMIN C HAND SANITIZER
ethyl alcohol formulation liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79655-804
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	38.35 mL in 59 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	18.88 mL in 59 mL
ORANGE (UNII: 5EVU04N5QU)	0.06 mL in 59 mL
LINALYL ACETATE (UNII: 5K47SSQ51G)	0.04 mL in 59 mL
DECANAL (UNII: 31Z90Q7KQJ)	0.01 mL in 59 mL
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)	0.03 mL in 59 mL
LINALOOL, (+/-)- (UNII: D81QY6I88E)	0.01 mL in 59 mL
CITRONELLYL NITRILE, (+/-)- (UNII: GP9AT16H16)	0.01 mL in 59 mL
CAPRYLALDEHYDE (UNII: XGE9999H19)	0.01 mL in 59 mL
NERAL (UNII: 8M466BQL1X)	0.01 mL in 59 mL
ETHYL ANTHRANILATE (UNII: 38Y050IUE4)	0.01 mL in 59 mL
2,4-DIMETHYL-3-CYCLOHEXENE CARBOXALDEHYDE (UNII: 452GFV2AFS)	0.01 mL in 59 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.885 mL in 59 mL
ALLYL HEXANOATE (UNII: 3VH84A363D)	0.01 mL in 59 mL
ETHYL MALTOL (UNII: L6Q8K29L05)	0.01 mL in 59 mL
.DELTA.-DAMASCONE (UNII: 7F4RIE5P7E)	0.01 mL in 59 mL
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)	0.06 mL in 59 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:79655-804-01	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/18/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/18/2020

Labeler - Kala Corporation (623014826)

Registrant - Kala Corporation (623014826)

Name	Address	ID/FEI	Business Operations
Establishment
Kala Corporation		623014826	manufacture(79655-804)