Medyskin Hand Sanitizer by Kira Labs Inc Medyskin Hand Sanitizer

Medyskin Hand Sanitizer by

Drug Labeling and Warnings

Medyskin Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Kira Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDYSKIN HAND SANITIZER- alcohol gel 
Kira Labs Inc

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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Medyskin Hand Sanitizer

Drug Facts

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use(s)

• Hand Sanitizer to help decrease bacteria on skin.

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash appears and lasts for more than 72 hours.

Keep out of reach of children.

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

Directions

• Put enough porduct in your palm to cover hands and rub hands together until dry.
• Children under 6 years should be supervised when using this product.

Inactive ingredients

Purified Water, Fragrance, PEG-6, Glycerin, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Propylene Glycol, Aloe Barbadensis Leaf Juice, Tocopherol

Package Labeling:

MEDYSKIN HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77816-502
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHEROL (UNII: R0ZB2556P8)
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77816-502-01	75 mL in 1 TUBE; Type 0: Not a Combination Product	08/10/2020	04/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/10/2020	04/30/2023

Labeler - Kira Labs Inc (132579397)

Revised: 7/2021

Document Id: c6eebbea-3a48-78b8-e053-2a95a90ac361

34390-5

Set id: b079a992-d45a-69e6-e053-2995a90a61d0

Version: 2

Effective Time: 20210712