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NDC 36800-0945-37 Hand Sanitizer 70 mg/100g Details

Hand Sanitizer 70 mg/100g

Hand Sanitizer is a TOPICAL AEROSOL, SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by TOPCO. The primary component is ALCOHOL.

Product Information

NDC	36800-0945
Product ID	36800-945_c8989cce-5519-1de4-e053-2995a90a9976
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	Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	AEROSOL, SPRAY
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mg/100g
Substance Name	ALCOHOL
Labeler Name	TOPCO
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0945-37 (36800094537)

Pricing Information	N/A
NDC Package Code	36800-945-37
Billing NDC	36800094537
Package	156 g in 1 CAN (36800-945-37)
Marketing Start Date	2020-05-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a578217c-46c4-e829-e053-2995a90a4684 Details

Active Ingredients

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Uses

hand sanitizer to help reduce bacteria on the skin that could cause disease.

Warnings

For external use only.

Flammable.

Keep away from heat or flame

Do not use

in children less than 2 months of age
on open skin wounds

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water to remove.
do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.

Stop use and ask a doctor if

rash or irritation occurs. These may be signs of a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

spray enough product in palm to thoroughly cover your hands
rub hands together briskly until dry
children under 6 years of age should be supervised when using this product.

Other information

may discolor or damage some fabrics/materials or surfaces.
Avoid freezing and excessive heat above 40ºC (104ºF)

Inactive ingredients

water, glycerin, aloe barbadensis leaf juice, tocopheryl acetate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER

alcohol aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-945
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-945-37	156 g in 1 CAN; Type 0: Not a Combination Product	05/18/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/18/2020

Labeler - TOPCO (006935977)

Revised: 8/2021

Document Id: c8989cce-5519-1de4-e053-2995a90a9976

Set id: a578217c-46c4-e829-e053-2995a90a4684

Version: 2

Effective Time: 20210802