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NDC 25113-0444-16 Instant Hand Sanitizer 665 mg/L Details

Instant Hand Sanitizer 665 mg/L

Instant Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Dodge. The primary component is ALCOHOL.

Product Information

NDC	25113-0444
Product ID	25113-444_db072baa-03b2-4847-a996-759e482d36ca
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	Instant Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	665
Active Ingredient Units	mg/L
Substance Name	ALCOHOL
Labeler Name	Dodge
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2023-12-31

Package

Package Images

NDC 25113-0444-16 (25113044416)

Pricing Information	N/A
NDC Package Code	25113-444-16
Billing NDC	25113044416
Package	.059 L in 1 BOTTLE (25113-444-16)
Marketing Start Date	2022-03-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c5e44a46-c198-4ecd-8624-560146bb5ea5 Details

Active ingredient

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Uses

for handwashing to decrease bacteria on skin
recommended for repeated use

Warnings

For external use only. Flammable, keep away from fire or flame.

Do not use in the eyes. If this happens, rinse thoroughly with water

Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours

Keep out of reach of children

If ingested get medical help or contact a Poison Control Center right away

Directions

wet hands thoroughly with product
allow to dry without wiping
children under 6 should be supervised while using this product

Inactive ingredients

aloe vera, carbomer, purified water, triethanolamine

Principal Display Panel - 59 mL Bottle Label

NDC 25113-444-16

Dodge

quiksan®

Instant

Hand

Santizer

MEETS CDC HANDWASHING RECOMMENDATIONS

Kills 99.9% of Germs

Enriched with Aloe Vera

Unscented

2 fl oz (59mL)

Made in U.S.A.

Principal Display Panel - 59 mL Bottle Label

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:25113-444
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M)	alcohol	665 mg in 1 L

Ingredient Name	Strength
Inactive Ingredients
aloe vera leaf (UNII: ZY81Z83H0X)
carbomer interpolymer type a (allyl sucrose crosslinked) (UNII: 59TL3WG5CO)
water (UNII: 059QF0KO0R)
trolamine (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:25113-444-16	0.059 L in 1 BOTTLE; Type 0: Not a Combination Product	03/18/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/18/2022

Labeler - Dodge (001045517)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	MANUFACTURE(25113-444)

Revised: 3/2022

Document Id: db072baa-03b2-4847-a996-759e482d36ca

Set id: c5e44a46-c198-4ecd-8624-560146bb5ea5

Version: 1

Effective Time: 20220309