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NDC 49348-0477-37 Advanced Hand Sanitizer 700 mg/mL Details

Advanced Hand Sanitizer 700 mg/mL

Advanced 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	49348-0477
Product ID	49348-477_da7b22ea-7790-440e-90b9-643d4665931a
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	Advanced 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	700
Active Ingredient Units	mg/mL
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 49348-0477-37 (49348047737)

Pricing Information	N/A
NDC Package Code	49348-477-37
Billing NDC	49348047737
Package	236 mL in 1 BOTTLE, PUMP (49348-477-37)
Marketing Start Date	2012-12-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 81c9bfe3-cf7a-4ed4-bdee-d3bd961228da 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 only

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

water, aloe, barbadensis leaf juice, glyceryl, caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4, blue 1, yellow 5

Claims

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

**This product is not manufactured or distributed by GOJO industries, Inc. distributor of Purell Refreshing Aloe 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

principal display panel

sunmark

COMPARE TO PURELL**

NDC 49348-477-37

advanced hand sanitizer

more effective formula

Kills more than 99.99% of germs*

WITH ALOE

8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

ADVANCED HAND SANITIZER

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-477
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	700 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SULISOBENZONE (UNII: 1W6L629B4K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49348-477-37	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/17/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/17/2012

Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(49348-477)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(49348-477)

Revised: 3/2022

Document Id: da7b22ea-7790-440e-90b9-643d4665931a

Set id: 81c9bfe3-cf7a-4ed4-bdee-d3bd961228da

Version: 13

Effective Time: 20220307