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NDC 76420-0708-02 Enovatizer 0.7 mL/mL Details

Enovatizer 0.7 mL/mL

Enovatizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Asclemed USA, Inc.. The primary component is ALCOHOL.

Product Information

NDC	76420-0708
Product ID	76420-708_a34d7f3c-a34c-0aa0-e053-2995a90a74b7
Associated GPIs	90971501304060
GCN Sequence Number	038829
GCN Sequence Number Description	ethyl alcohol GEL (ML) 70 % TOPICAL
HIC3	Q5B
HIC3 Description	TOPICAL PREPARATIONS,ANTIBACTERIALS
GCN	15153
HICL Sequence Number	001681
HICL Sequence Number Description	ETHYL ALCOHOL
Brand/Generic	Generic
Proprietary Name	Enovatizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	0.7
Active Ingredient Units	mL/mL
Substance Name	ALCOHOL
Labeler Name	Asclemed USA, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2023-12-31

Package

Package Images

NDC 76420-0708-02 (76420070802)

Pricing Information	N/A
NDC Package Code	76420-708-02
Billing NDC	76420070802
Package	60 mL in 1 BOTTLE (76420-708-02)
Marketing Start Date	2020-04-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL aed5f917-09d3-44e0-b26f-c78955b4491b Details

Drug Facts

Active ingredient

Ethyl Alcohol 70%

Purpose

Topical Antimicrobial

Uses

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

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 eyes 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.

Directions

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

Other information

Store between 15°-30°C (59°-86°F).
Avoid freezing and excessive heat above 40ºC (104ºF).

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aminomethylpropanediol, Aqua (Deionized Water), Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polysorbate-20

PRINCIPAL DISPLAY PANEL

NDC 76420-708-02

Enovatizer TM

Gel

2 fl.oz (60 ml)

Distributed by:

Enovachem

PHARMACEUTICALS

Torrance, CA 90501

(310) 320-0100

INGREDIENTS AND APPEARANCE

ENOVATIZER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76420-708
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76420-708-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/15/2020

Labeler - Asclemed USA, Inc. (059888437)

Revised: 4/2020

Document Id: a34d7f3c-a34c-0aa0-e053-2995a90a74b7

Set id: aed5f917-09d3-44e0-b26f-c78955b4491b

Version: 1

Effective Time: 20200415