Novospray by KEY QUIMICA S.A. DE C.V. 58345-200

Novospray by

Drug Labeling and Warnings

Novospray 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]

NOVOSPRAY- alcohol spray 
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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58345-200

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

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

Warnings

Flammable, keep away from fire or flame. For external use only.

Do not use

this product in or near the eyes.

Stop use if irritation or redness develop. if conditions persist for more than 72 hours, consult a doctor.

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, fragrance, glycereth-7 triacetate, alpha-tocopherol and denatonium benzoate.

Package Label - Principal Display Panel

NOVOSPRAY 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58345-200
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
GLYCERETH-7 TRIACETATE (UNII: S9W6Z48HUP)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58345-200-01	12 in 1 BOX	03/30/2020
1		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58345-200-02	12 in 1 BOX	03/30/2020
2		500 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58345-200-03	6 in 1 BOX	03/30/2020
3		960 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 58345-200-04	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 58345-200-05	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

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: 4/2021

Document Id: c090d88b-cbde-525a-e053-2995a90a10c5

34390-5

Set id: ac493223-089b-6c46-e053-2a95a90a9a96

Version: 4

Effective Time: 20210422