ALTITUDE MEDICAL HAND SANITIZER- ethyl alcohol gel

Altitude Medical Hand Sanitizer by

Drug Labeling and Warnings

Altitude Medical Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Altitude Medical, CYAN Labs S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Ethyl alcohol, 69.8% v/v

Purpose

Antimicrobial

Uses

• Sanitize hands without requiring water or a rinse

Warnings

Flammable

For external use only

When using this product

• Do not use near heat or flame
• Do not use in or near eyes
• Discontinue use if irritation and redness develop
• Do not use on deep or puncture wounds, consult your doctor

Keep out of reach of children.

In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions

• apply gel liberally to unsoiled hands and rub in thoroughly
• allow to dry without wiping or rinsing

Other information

• Store at room temperature

Inactive ingredients

Water, glycerin, carbomer, glycereth-7 triacetate, triethanolamine, fragrance and tocopherol acetate.

PRINCIPAL DISPLAY PANEL

AltitudeMedical
Hand Sanitizer
Kills 99.999% of germs without water!
Net Contents 5/408mL (13.5 Fl oz)
Emergency #
1-888-959-0211

PRINCIPAL DISPLAY PANEL

AltitudeMedical™
Hand Sanitizer
Kills 99.999% of germs without water!
Net Contents 4/500mL (16.9 Fl oz)
Emergency # : 1-888-959-0211

PRINCIPAL DISPLAY PANEL

AltitudeMedical™
Hand Sanitizer
Kills 99.999% of germs without water!
Net Contents 4/465mL (15.7 Fl oz)
Emergency # : 1-888-959-0211

INGREDIENTS AND APPEARANCE

ALTITUDE MEDICAL HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69345-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	69.8 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69345-200-01	5 in 1 BOX	12/07/2016
1		408 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69345-200-02	4 in 1 BOX	08/30/2018
2		500 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 69345-200-03	4 in 1 BOX	10/30/2018
3		4 in 1 BOX
3		465 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	part333E	12/07/2016

Labeler - Altitude Medical (963401380)

Registrant - CYAN Labs S.A. de C.V. (812754130)

Establishment
Name	Address	ID/FEI	Business Operations
CYAN Labs S.A. de C.V.		812754130	manufacture(69345-200) , label(69345-200) , pack(69345-200)