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NDC 66294-0965-34 PRIME SOURCE Hand Sanitizer 0.62 mL/mL Details

PRIME SOURCE Hand Sanitizer 0.62 mL/mL

PRIME SOURCE Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by BUNZL. The primary component is ALCOHOL.

Product Information

NDC	66294-0965
Product ID	66294-965_d2ce6586-4eb4-403f-924c-666e703f0412
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	PRIME SOURCE Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	0.62
Active Ingredient Units	mL/mL
Substance Name	ALCOHOL
Labeler Name	BUNZL
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 66294-0965-34 (66294096534)

Pricing Information	N/A
NDC Package Code	66294-965-34
Billing NDC	66294096534
Package	1000 mL in 1 PACKAGE (66294-965-34)
Marketing Start Date	2002-09-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b49dd03d-7718-4a4c-8df4-96a6c1ebf13f Details

Active ingredient

Ethyl alcohol 62%

Purpose

Antimicrobial

Use

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

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

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 thoroughly cover your hands
Rub hands together briskly until dry
Children under 6 years of age should be supervised when using this product.

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Diisopropyl Sebacate, Glycerin, Isopropyl Myristate, Propylene Glycol, Tocopheryl Acetate, Aminomethyl Propanol, Carbomer, Fragrance (Parfum)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRIME SOURCE HAND SANITIZER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66294-965
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66294-965-34	1000 mL in 1 PACKAGE; Type 0: Not a Combination Product	09/30/2002

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/30/2002

Labeler - BUNZL (799540588)

Revised: 10/2012

Document Id: d2ce6586-4eb4-403f-924c-666e703f0412

Set id: b49dd03d-7718-4a4c-8df4-96a6c1ebf13f

Version: 1

Effective Time: 20121015