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NDC 15127-0007-16 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 Select Brand Distributors. The primary component is ALCOHOL.

Product Information

NDC	15127-0007
Product ID	15127-007_e3787663-9b0a-4e1e-b5fa-2aad97e4738f
Associated GPIs	64200010000315
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	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	Select Brand Distributors
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 15127-0007-16 (15127000716)

Pricing Information	N/A
NDC Package Code	15127-007-16
Billing NDC	15127000716
Package	59 mL in 1 BOTTLE, PUMP (15127-007-16)
Marketing Start Date	2014-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5639f496-c76c-43b8-bffe-c67d4860b717 Details

Active Ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Uses

to decrease bacteria on the skin that could cause disease
recommend 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

irritation or redness develops
condition persists for more than 72 hours

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 store 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

**This product is not manufactured or distributed by GOJO Industries, Inc. distributor of PURELL Refreshing Gel Advanced Hand Sanitizer.

Distributed by: Select Brand Distrutors

Pine Bluff, AR 71603 USA AC (870)-535-3635

Patent Pending

principal display panel

Select brand the lower price name brand

More Effective Formula

Advanced Hand Sanitizer

Kills more than 99.99% of germs*

Compare to PURELL**

8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

HAND SANITIZER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:15127-007
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:15127-007-16	59 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2014
2	NDC:15127-007-34	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/01/2014

Labeler - Select Brand Distributors (012578514)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(15127-007)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(15127-007)

Revised: 3/2022

Document Id: e3787663-9b0a-4e1e-b5fa-2aad97e4738f

Set id: 5639f496-c76c-43b8-bffe-c67d4860b717

Version: 14

Effective Time: 20220303