Hand Sanitizing Gel (69219-105) - DELIST

IS Clinical Hand Sanitizing Gel by

Drug Labeling and Warnings

IS Clinical Hand Sanitizing Gel by is a Otc medication manufactured, distributed, or labeled by Science of Skincare, Kdc/One Socal Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IS CLINICAL HAND SANITIZING GEL- ethyl alcohol gel 
Science of Skincare

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hand Sanitizing Gel (69219-105) - DELIST

Ethyl Alcohol 62% v/v

Antiseptic

to help reduce bacteria on the skin.

For external use only.

Flammable, keep away from fire or flame.

Stop use and ask a doctor if irritation or redness develops.

When using this product avoid contact with eyes. If eye contact occurs, rinse with water.

Keep out of reach of children. In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

When using this product avoid contact with eyes. If eye contact occurs, rinse with water.

Apply enough gel to wet hands and rub together until dry. Use 1 to 3 times daily.

Do not store above 104F/40C

Aloe Barbadensis Leaf Juice, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxyethylcellulose, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Water(Aqua), May contain Isopropyl Alcohol

IS CLINICAL HAND SANITIZING GEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69219-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
ROSEMARY (UNII: IJ67X351P9)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69219-105-01	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/06/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/01/2020	12/31/2021

Labeler - Science of Skincare (006251958)

Establishment
Name	Address	ID/FEI	Business Operations
V Manufacturing & Logistics, Inc.		825176857	manufacture(69219-105)

Revised: 10/2022

Document Id: ec58d537-cc93-1219-e053-2995a90af262

34390-5

Set id: b6387d2a-f95c-5c1b-e053-2a95a90a83eb

Version: 4

Effective Time: 20221031