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NDC 73145-0008-01 ANTIBACTERIAL HAND SANITIZER 70 mL/100mL Details

ANTIBACTERIAL HAND SANITIZER 70 mL/100mL

ANTIBACTERIAL HAND SANITIZER is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by ASC Marketing Ltd.. The primary component is ALCOHOL.

Product Information

NDC	73145-0008
Product ID	73145-008_b41d75da-55f2-a244-e053-2a95a90a976e
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	ANTIBACTERIAL HAND SANITIZER
Proprietary Name Suffix	n/a
Non-Proprietary Name	ETHYL ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	ASC Marketing Ltd.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 73145-0008-01 (73145000801)

Pricing Information	N/A
NDC Package Code	73145-008-01
Billing NDC	73145000801
Package	236 mL in 1 BOTTLE, PUMP (73145-008-01)
Marketing Start Date	2020-11-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b41d75da-55f1-a244-e053-2a95a90a976e Details

Active ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Uses

for handwashing to decrease bacteria on the skin.
recommended for repeated use.

Warnings

For external use only.

When using this product

Do not use in eyes.
Discontinue use if irritation and redness develop.
Flammable, keep away from fire or flame.

Keep out of reach of children

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

If pregnant or breast-feeding, ask a health professional before use.

Directions

wet hands thoroughly with product.
briskly rub hands together until dry.

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Aloe Barbadensis Leaf Juice, Maltodextrin, Triethanolamine.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND SANITIZER

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73145-008
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
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73145-008-01	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/16/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/16/2020

Labeler - ASC Marketing Ltd. (117025198)

Revised: 11/2020

Document Id: b41d75da-55f2-a244-e053-2a95a90a976e

Set id: b41d75da-55f1-a244-e053-2a95a90a976e

Version: 1

Effective Time: 20201113