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NDC 71569-0370-88 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 Jubilant, LLC. The primary component is ALCOHOL.

Product Information

NDC	71569-0370
Product ID	71569-370_3e26cfcc-8cf7-4b64-814b-72c01f218d1e
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	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	Jubilant, 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 71569-0370-88 (71569037088)

Pricing Information	N/A
NDC Package Code	71569-370-88
Billing NDC	71569037088
Package	2000 mL in 1 BOTTLE, PUMP (71569-370-88)
Marketing Start Date	2017-07-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d559ff3d-a4a5-4a3d-a489-134760584c95 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

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

DISTRIBUTED BY: Jubilant LLC

451 Broadway, F12

New York, NY 10013

www.princeSpring.com

Pat. 9,161,982

SDS-MO-15036

SDA-WI-2486

DSP-MO-28

DSP-MO-34

Questions? Comments? 732-783-4090

[email protected]

principal display panel

Prince & Spring

Advanced Hand Sanitizer

Moisturizing formula with Vitamin E

Kills more than 99.99% of germs*

Get a hand-le on germs

67.6 FL OZ (2 L)

INGREDIENTS AND APPEARANCE

HAND SANITIZER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71569-370
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	Marketing End Date
Packaging
1	NDC:71569-370-88	2000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/11/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/11/2017

Labeler - Jubilant, LLC (079508724)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(71569-370)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(71569-370)

Revised: 3/2022

Document Id: 3e26cfcc-8cf7-4b64-814b-72c01f218d1e

Set id: d559ff3d-a4a5-4a3d-a489-134760584c95

Version: 12

Effective Time: 20220303