Medyskin Anti-Microbial Cleanser with Vitamin E

Medyskin Anti-Microbial Cleanser with Vitamin E by

Drug Labeling and Warnings

Medyskin Anti-Microbial Cleanser with Vitamin E by is a Otc medication manufactured, distributed, or labeled by Kira Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDYSKIN ANTI-MICROBIAL CLEANSER WITH VITAMIN E- benzalkonium chloride 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 Anti-Microbial Cleanser with Vitamin E

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Use(s)

• Helps eliminate bacteria on skin

Warnings

For external use only.

When using this product

avoid contact with eyes. In case of contact, flush eyes 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

• Apply to hands or body, wash and rinse.
• Children under 6 years should be supervised when using this product.

Inactive ingredients

Purified Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamide MEA, Cocamidopropyl Betaine, Sodium Chloride, Fragrance, Propylene Glycol, Methylchloroisothiazolinone, Methylisothiazolinone, Disodium EDTA, Tocopherol, Glycerin, Aloe Barbadensis Leaf Juice, Citric Acid

Package Labeling: 960 ml

Package Labeling: 480 ml

MEDYSKIN ANTI-MICROBIAL CLEANSER WITH VITAMIN E 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77816-505
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77816-505-01	960 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020	10/01/2020
2	NDC: 77816-505-02	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/01/2020	12/31/2022

Labeler - Kira Labs Inc (132579397)

Revised: 7/2021

Document Id: c6eefbc0-f0da-7c4d-e053-2a95a90a6e23

34390-5

Set id: b079b8cd-dc88-91ee-e053-2995a90aae41

Version: 3

Effective Time: 20210712