Novogel by KEY QUIMICA S.A. DE C.V.

Novogel by

Drug Labeling and Warnings

Novogel by is a Otc medication manufactured, distributed, or labeled by KEY QUIMICA S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NOVOGEL- alcohol gel 
KEY QUIMICA S.A. DE C.V.

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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Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Uses

To decrease bacteria on skin that could cause diseases. Recommended for reapeted use.

Warnings

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

Do not use

this product in or near the eyes.

Stop use if irritation or redness develop. If condition persists for more than 72 hours, consult a doctoer.

Keep out of reach of children. If swallowed, seek immediate medical attention or call a poison control center.

Directions

• wet hands thoroughly with product and allow to dry without wiping.

Inactive ingredients

Water (aqua), glycerin, carbomer, triethanolamine, fragrance, glycereth-7 triacetate, alpha-tocopherol and denatonium benzoate.

Package Label - Principal Display Panel

NOVOGEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58345-100
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERETH-7 TRIACETATE (UNII: S9W6Z48HUP)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58345-100-01	3 in 1 BOX	03/30/2020
1		1000 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58345-100-02	6 in 1 BOX	03/30/2020
2		960 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58345-100-03	4 in 1 BOX	03/30/2020
3		4000 mL in 1 JUG; Type 0: Not a Combination Product
4	NDC: 58345-100-04	3 in 1 BOX	03/30/2020
4		4000 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - KEY QUIMICA S.A. DE C.V. (810740548)

Revised: 3/2021

Document Id: bd1db452-fa56-0264-e053-2995a90af617

34390-5

Set id: ac3a1009-1646-57ce-e053-2995a90a6fcb

Version: 3

Effective Time: 20210309