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NDC 49967-0998-01 Kiehls Since 1851 Clean Strength Antiseptic Hand Sanitizer 71 L/100L Details

Kiehls Since 1851 Clean Strength Antiseptic Hand Sanitizer 71 L/100L

Kiehls Since 1851 Clean Strength Antiseptic Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by L'Oreal USA Products Inc. The primary component is ALCOHOL.

Product Information

NDC	49967-0998
Product ID	49967-998_a405da3d-c805-4502-ad51-4cb9b6b15b7a
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	Kiehls Since 1851 Clean Strength Antiseptic Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	71
Active Ingredient Units	L/100L
Substance Name	ALCOHOL
Labeler Name	L'Oreal USA Products Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	n/a

Package

Package Images

NDC 49967-0998-01 (49967099801)

Pricing Information	N/A
NDC Package Code	49967-998-01
Billing NDC	49967099801
Package	.12 L in 1 TUBE (49967-998-01)
Marketing Start Date	2021-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 68848e9d-8de0-4ed3-9eb0-bf7a8df1de6d Details

Active ingredient

Alcohol 71% v/v

Purpose

Antiseptic

Use

hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from fire or heat.

Do not use

in children less than 2 months of age
on open skin wounds

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation or rash appears and lasts

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

place enough product on hands to cover all surfaces. Rub hands together until dry.
supervise chlildren under 6 years of age when using this product to avoid swallowing

Other information

● store between 15°- 30°C (59° - 86°F)

● avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

water, glycerin, polyacryloyldimethyl taurate, eucalyptus globulus leaf oil, rosmarinus officinalis (rosemary) leaf oil, limonene, linalool

Questions or comments?

Call toll free 1-800-946-4453

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIEHLS SINCE 1851 CLEAN STRENGTH ANTISEPTIC HAND SANITIZER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49967-998
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	71 L in 100 L

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ROSEMARY OIL (UNII: 8LGU7VM393)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49967-998-01	0.120 L in 1 TUBE; Type 0: Not a Combination Product	02/01/2021	06/02/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/01/2021	06/02/2023

Labeler - L'Oreal USA Products Inc (002136794)

Name	Address	ID/FEI	Business Operations
Establishment
L'Oreal USA Products Inc		624244349	manufacture(49967-998)

Revised: 6/2022

Document Id: a405da3d-c805-4502-ad51-4cb9b6b15b7a

Set id: 68848e9d-8de0-4ed3-9eb0-bf7a8df1de6d

Version: 2

Effective Time: 20220630