SPECTRAGENIX HAND SANITIZER ANTISEPTIC HAND WASH- ethyl alcohol liquid
Medical Chemical 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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SpectraGenix Hand Sanitizer

Purpose

Germicide

Active Ingredients

Ethyl Alcohol 70% v/v

Inactive Ingredients

Purified water, Emollients (Laurel, Myristal and Cetyl Lactate,), Aloe Vera, Carbomer, Parabens, Diisopropylamine

Warnings

Warnings: Flammable, keep away from fire or flame. For external use only. Do no use in the eyes. Discontinue use if irritation or redness develops. Keep out of reach of children. In case of ingestion contact poison control center immediately.

Warnings

Danger: Highly flammable liqid and vapor. Keep away from heat, sparks, open flames and hot surfaces. No smoking. Keep container tightly closed. Use only non-sparking tools. Take precautions against static discharge. In case of fire, use fire extinguishers approved for alcohol fires. In case of ingestion contact a poison control center. Discontinue use if irritation or redness develops. Keep out of reach of children.

Directions

Spray about 5 g (1 tsp.) on to one hand and spread over both hands to the wrist. Rub into the skin until dry. Repeat.

Uses

Intended for use as a hand sanitizer to reduce pathogenic bacteria. Recommended for repeated use. For external use on the skin only. Not for use on the eyes.

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spectragenixlabel

SPECTRAGENIX HAND SANITIZER ANTISEPTIC HAND WASH
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12745-850
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	55.34 g in 100 mL
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) (DIAZOLIDINYL UREA - UNII:H5RIZ3MPW4)	DIAZOLIDINYL UREA	0.167 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SPIKE LAVENDER OIL (UNII: 7S2HYV1VJQ)	0.02 g in 100 mL
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)	4 g in 100 mL
CETYL LACTATE (UNII: A7EVH2RK4O)	0.5 g in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.5 g in 100 mL
DIISOPROPYLAMINE (UNII: BR9JLI40NO)	0.29 g in 100 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:12745-850-01	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/23/2020
2	NDC:12745-850-02	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/23/2020
3	NDC:12745-850-03	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/23/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/23/2020

Labeler - Medical Chemical Corporation (008496861)

Registrant - Medical Chemical Corporation (008496861)

Name	Address	ID/FEI	Business Operations
Establishment
Medical Chemical Corporation		008496861	manufacture(12745-850)