390 FIT FOR HEALTH 70 ALCOHOL TOPICAL SOLUTION- alcohol gel
Tangible Nous, 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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390 Fit for Health 70 Alcohol Topical Solution

Drug Facts

Active ingredient(s)

Ethanol 70%

Purpose.

Antibacterial.

Use(s)

Hand Sanitizer.

Warnings

Highly flammable liquid and vapor.
Keep away from heat/sparks/open flames/hot surfaces

Do not swallow,

if swallows get medical help and contact the nearest poison centre.

When using this product

keep out of eyes, in case of contact with eyes, rinse with water.

Stop use and ask a doctor

if irritation and redness develops and persists.

Keep out of reach of chilldren

Keep out of sight and reach of children.

Directions:

Wet hand thoroughly with product and allow to dry without wiping.

Other information:

Store between 15-30 ºC (59-86 ºF) and out of direct sunlight, do not mix with other products, Dispose of contents/container in accordance with local/regional regulations.

Inactive Ingredients:

Glycerin, Polyethylene Oxide, Polygel HG, Triethanolamine, Ethanol, Peroxide, Water (q.s).

Package Labeling:

Bottle

390 FIT FOR HEALTH 70 ALCOHOL TOPICAL SOLUTION
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79676-000
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
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:79676-000-01	3780 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	07/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/01/2020

Labeler - Tangible Nous, S.A. de C.V. (814498135)