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NDC 49348-0405-31 Hand Sanitizer 70 mL/100mL Details

Hand Sanitizer 70 mL/100mL

Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by STRATEGIC SOURCING SERVICES LLC. The primary component is ALCOHOL.

Product Information

NDC	49348-0405
Product ID	49348-405_d481aee7-d815-4def-882b-d75070246d11
Associated GPIs	90971501300951
GCN Sequence Number	038829
GCN Sequence Number Description	ethyl alcohol GEL (ML) 70 % TOPICAL
HIC3	Q5B
HIC3 Description	TOPICAL PREPARATIONS,ANTIBACTERIALS
GCN	15153
HICL Sequence Number	001681
HICL Sequence Number Description	ETHYL ALCOHOL
Brand/Generic	Generic
Proprietary Name	Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	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	STRATEGIC SOURCING SERVICES LLC
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 49348-0405-31 (49348040531)

Pricing Information	N/A
NDC Package Code	49348-405-31
Billing NDC	49348040531
Package	59 mL in 1 BOTTLE, PLASTIC (49348-405-31)
Marketing Start Date	2013-01-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 96bc1495-0633-4348-bfce-7ee2c4eaf04c Details

Active Ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Uses

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 thoroghly 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 sore above 105⁰ F
may discolor some fabrics
harmful to wood finishes and plastics

Inactive ingredients

water, glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4

SPL UNCLASSIFIED SECTION

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

Not manufactured or distributed by GOJO industries, Inc. distributor of Purell Refreshing Gel Advanced Hand Sanitizer**

Made in USA with US and foreign components

Another Quality Product Distributed By McKesson

One Post Street, San Francisco, CA 94104

Money Back Guarantee

Please visit us at www.sunmarkbrand.com

SDS-MO-15036 SDA-WI-2486 DSP-MO-28 DSP-MO-34

principal display panel

Sunmark

COMPARE TO PURELL**

NDC 49348-405-37

hand sanitizer

more effective formula

Kills more than 99.99% of germs*

ADVANCED

8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

HAND SANITIZER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-405
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
water (UNII: 059QF0KO0R)
GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
SULISOBENZONE (UNII: 1W6L629B4K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49348-405-31	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/21/2013
2	NDC:49348-405-37	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/21/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/21/2013

Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(49348-405)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(49348-405)

Revised: 3/2022

Document Id: d481aee7-d815-4def-882b-d75070246d11

Set id: 96bc1495-0633-4348-bfce-7ee2c4eaf04c

Version: 11

Effective Time: 20220307