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NDC 68196-0951-16 Hand Sanitizer 578 mg/mL Details

Hand Sanitizer 578 mg/mL

Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Sam's West Inc. The primary component is ALCOHOL.

Product Information

NDC	68196-0951
Product ID	68196-951_f00c2141-4bc5-4733-a9ca-50a5b7ca73a2
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	Ethyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	578
Active Ingredient Units	mg/mL
Substance Name	ALCOHOL
Labeler Name	Sam's West Inc
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 68196-0951-16 (68196095116)

Pricing Information	N/A
NDC Package Code	68196-951-16
Billing NDC	68196095116
Package	59 mL in 1 BOTTLE, PLASTIC (68196-951-16)
Marketing Start Date	2014-09-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 48960ca2-ddd6-40dc-bc21-25bb52f52ef2 Details

Active ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Use

to decrease bacteria on the skin that could cause disease
recommended for repeated use

Warnings

For external use only-hands

Flammable. Keep away from heat and flame.

When using this product

keep out of eyes. In case of contact with eyes, flush thoroughly with water
avoid contact with broken skin
do not inhale or ingest

Stop use and ask a doctor if

skin irritation develops.

Keep out of reach of children.

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

Directions

wet hands thoroughly with product and allow to dry without wiping
for children under 6, use only under adult supervision
not recommended for infants

Other information

do not store above 105⁰ F
may discolor some fabrics
harmful to wood finishes and plastics

Inactive ingredients

benzophenone-4, carbomer, fragrance, glycerin, isopropyl myristate, propylene glycol, tocopheryl acetate, water

SPL UNCLASSIFIED SECTION

*Effective at eliminating 99.99% of many common harmful germs and bacteria in as little as 15 seconds

Distributed by SAM'S West, Inc.

608 S.W. 8th Street

Bentonville, AR 72716

This product not packaged for resale

principal display panel

Member's Mark Quality Guaranteed

Hand Sanitizer

Kills 99.99% of germs*

Plus Moisturizers and Vitamin E

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

HAND SANITIZER

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68196-951
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	578 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SULISOBENZONE (UNII: 1W6L629B4K)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
glycerin (UNII: PDC6A3C0OX)
isopropyl myristate (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68196-951-16	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/08/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/08/2014

Labeler - Sam's West Inc (051957769)

Registrant - Vi-Jon, LLC (088520668)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(68196-951)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(68196-951)

Revised: 9/2022

Document Id: f00c2141-4bc5-4733-a9ca-50a5b7ca73a2

Set id: 48960ca2-ddd6-40dc-bc21-25bb52f52ef2

Version: 10

Effective Time: 20220913