Hestia Clinic Gel Hand Sanitizer by DANS-K Medical Supplies LLC

Drug Details [pdf]

HESTIA CLINIC GEL HAND SANITIZER- alcohol gel
DANS-K Medical Supplies LLC

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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Drug Facts

Active ingredient: Purpose

Ethyl Alcohol 62% m/m…………...………………….Antiseptic

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduce bacteria on the skin that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

· in children less than 2 months of age, without consulting a physician

· 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 occurs. These may be signs of a serious condition.

· side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

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 briskly until dry.

· Place more hand sanitizer into palm, and rub into fingernails to disinfect.

· Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 1-30C (34-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Alcohol, Water, Carbomer, Triethanolamine, PEG-60 Hydrogenated Castor Oil, Lavandula Angustifolia (Lavender) Oil, Methylparaben, Butylene Glycol, 1, 2-Hexanediol, Glycosaminoglycans, Fragaria Chiloensis (Strawberry) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Punica Granatum Fruit Extract, Citrullus Vulgaris (Watermelon) Fruit Extract, Solanum Lycopersicum (Tomato) Fruit Extract, Capsicum Annuum Fruit Extract

Label

100 mL NDC: 74002-0100

Label

HESTIA CLINIC GEL HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79656-0100(NDC: 74002-0100)
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
APPLE (UNII: B423VGH5S9)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
METHYLPARABEN (UNII: A2I8C7HI9T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TROLAMINE (UNII: 9O3K93S3TK)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T)
POMEGRANATE (UNII: 56687D1Z4D)
TOMATO (UNII: Z4KHF2C175)
CAPSICUM (UNII: 00UK7646FG)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
LAVENDER OIL (UNII: ZBP1YXW0H8)
WATER (UNII: 059QF0KO0R)
WATERMELON (UNII: 231473QB6R)
STRAWBERRY (UNII: 4J2TY8Y81V)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 79656-0100-1	100 mL in 1 TUBE; Type 0: Not a Combination Product	04/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/15/2020	02/27/2023

Labeler - DANS-K Medical Supplies LLC (117482010)

Revised: 8/2020

Document Id: ad165e36-270c-3527-e053-2995a90a6d2a

Set id: a8cdc5b3-6049-381d-e053-2a95a90a78ac

Version: 3

Effective Time: 20200811