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NDC 70000-0462-01 Hand Sanitizer 0.7 mL/mL Details

Hand Sanitizer 0.7 mL/mL

Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health< 110 dba Leader. The primary component is ALCOHOL.

Product Information

NDC	70000-0462
Product ID	70000-0462_f49a1710-e946-466d-93b1-c8b4ffa52845
Associated GPIs	90971501304060
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	0.7
Active Ingredient Units	mL/mL
Substance Name	ALCOHOL
Labeler Name	Cardinal Health< 110 dba Leader
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70000-0462-01 (70000046201)

Pricing Information	N/A
NDC Package Code	70000-0462-1
Billing NDC	70000046201
Package	236 mL in 1 BOTTLE, PUMP (70000-0462-1)
Marketing Start Date	2012-11-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 32da7195-81c3-4318-bbb5-c2e0ccde942d 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
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 thoroughly with product and allow to dry witout 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

Questions?

1-888-593-0593

SPL UNCLASSIFIED SECTION

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

*This product is not manufactured or distributed by GOJO Industries, Inc. owner of the registered trademark Purell

Pat. 9,161,982

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

100% Money back guarantee. Return to place of purchase if not satisfied.

principal display panel

NDC 70000-0462-1

LEADER

Compare to Purell*

Advanced Hand Sanitizer with Aloe

More effective formula

Kills more than 99.99% of germs†

Moisturizing formula with aloe and Vitamin E

8 FL OZ (236 mL)

100% money back guarantee

†

INGREDIENTS AND APPEARANCE

HAND SANITIZER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0462
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.70 mL 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:70000-0462-1	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/09/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/09/2012

Labeler - Cardinal Health< 110 dba Leader (063997360)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(70000-0462)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(70000-0462)

Revised: 3/2022

Document Id: f49a1710-e946-466d-93b1-c8b4ffa52845

Set id: 32da7195-81c3-4318-bbb5-c2e0ccde942d

Version: 28

Effective Time: 20220302