ENVIRO E3 RATED SANITIZER- ethanol alcohol liquid
IMPERIAL VALLEY DISTRIBUTING, INC

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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ENVIRO E3 RATED sanitizer

Active ingredient

Ethanol Alcohol 70% v/v

Purpose

Antimicrobial

Uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease.
Recommended for repeat use.

Warnings

Flammable. Keep away from fire or flame

For external use only.

When using this product

- Do not use in or near the eyes.
- In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

- If irritation or rash appears and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product in your palm to thoroughly cover your hands.
Rub hands together briskly until dry.
No rinsing required.
No towels needed

Other information

Do not store above 110⁰F(43⁰C).

- May discolor certain fabrics or surfaces.

Inactive ingredients

Water, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Triethanolamine, Acrylates/C10-C30 Alkyl Akrylate, Crosspolymer

Product Label

image description

ENVIRO E3 RATED SANITIZER
ethanol alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74693-001
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74693-001-01	800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/07/2020
2	NDC:74693-001-02	1000000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/07/2020
3	NDC:74693-001-03	37854 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/07/2020

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

Labeler - IMPERIAL VALLEY DISTRIBUTING, INC (062212557)

Name	Address	ID/FEI	Business Operations
Establishment
M CHEM S.A DE C.V.		951576034	manufacture(74693-001)