Medyskin Hand Sanitizer by Kira Labs Inc Medyskin Hand Sanitizer

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 reduce bacteria that potentially can cause disease.
For use when soap & water are not available.

Warnings

Flammable. Keep away from fire or flame.

For external use only.

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 occurs. These may be signs of a serious condition.

Keep out of reach of children.

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

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children 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

Carbomer, Glycerin, Propylene Glycol, Purified Water, Triethanolamine

Package Labeling:30ml

Label

Package Labeling:480ml

Label2

Package Labeling:75ml

Label3

Package Labeling:630ml

Label4

Package Labeling:960ml

Label5

Package Labeling:240ml

Label6

MEDYSKIN HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77816-500
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 77816-500-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020	03/31/2022
2	NDC: 77816-500-02	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020	05/31/2022
3	NDC: 77816-500-05	75 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2020	04/30/2023
4	NDC: 77816-500-08	630 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020	06/30/2022
5	NDC: 77816-500-03	960 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020	07/31/2022
6	NDC: 77816-500-04	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020	05/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/01/2020	04/30/2023

Labeler - Kira Labs Inc (132579397)

Revised: 7/2021

Document Id: c6ee9118-4b95-6c57-e053-2a95a90a3322

Set id: afd451cc-966e-38ed-e053-2a95a90a0803

Version: 2

Effective Time: 20210712