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NDC 69345-0300-01 Altitude Medical Hand Sanitizer 70 mL/100mL Details

Altitude Medical Hand Sanitizer 70 mL/100mL

Altitude Medical Hand Sanitizer is a TOPICAL GEL, METERED in the HUMAN OTC DRUG category. It is labeled and distributed by Altitude Medical. The primary component is ALCOHOL.

Product Information

NDC	69345-0300
Product ID	69345-300_d4b806c0-fb01-db13-e053-2995a90a6674
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Altitude Medical Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethyl Alcohol, 70%
Product Type	HUMAN OTC DRUG
Dosage Form	GEL, METERED
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Altitude Medical
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 69345-0300-01 (69345030001)

Pricing Information	N/A
NDC Package Code	69345-300-01
Billing NDC	69345030001
Package	408 mL in 1 CARTRIDGE (69345-300-01)
Marketing Start Date	2021-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cfc4d25a-03e7-0619-e053-2995a90ac6fb Details

ACTIVE INGREDIENT

Ethyl alcohol …….. 70% v/v

PURPOSE

Antiseptic

USE

Hand sanitizer to help reduce bacteria on the skin

WARNINGS

Flammable. Keep away from heat or flame.

For external use only: hands

WHEN USING

When using this product do not use in or near eyes.

In case of contact, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash occurs and lasts.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

DIRECTIONS

• Place enough product in your palm to cover hands and rub hands together briskly until dry.

• Children under 6 years of age should be supervised when using this product.

OTHER INFORMATION

• Store below 100°F (43°C)

• May discolor certain fabrics or surfaces.

INACTIVE INGREDIENTS

Glycerin, isopropyl alcohol, PEG-6 (and) AMP-acrylates/vinyl isodecanoate crosspolymer, purified water

Altitude Medical PullClean Carton Label, 5/408mL, NDC 69345-300-01

Altitude Medical PullClean Cartridge Label, 408mL, NDC 69345-300-01

INGREDIENTS AND APPEARANCE

ALTITUDE MEDICAL HAND SANITIZER

ethyl alcohol, 70% gel, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69345-300
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL ALCOHOL (UNII: ND2M416302)
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69345-300-01	408 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	11/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/01/2021

Labeler - Altitude Medical (963401380)

Revised: 1/2022

Document Id: d4b806c0-fb01-db13-e053-2995a90a6674

Set id: cfc4d25a-03e7-0619-e053-2995a90ac6fb

Version: 2

Effective Time: 20220103