Drug Labeling and Warnings

Drug Details [pdf]

MEDICATED NO MESS APPLICATOR- menthol liquid 
Essentials Biotech Co, Ltd

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.

----------

Active Ingredient..........................Purpose

Menthol 16%................................Topical analgesic

Uses

temporarily relieves minor pain associated with

• arthritis
• simple backache
• bruises
• cramps
• muscle strain
• sprains

WARNING: EXTERNAL USE ONLY

When using this product

• use only as directed
• do not bandage tightly or cover treated area
• do not use with a heating pad
• avoid contact with eyes and mucous membranes
• do not apply to wounds or damaged, broken or irritated skin
• a temporary burning sensation may occur opon application but typically disappears in several days
• if severe burning sensation occurs, discontinue use immediately
• do not expose the area treated with product to heat or direct sunlight

Stop use and ask a doctor if

condition worsens

redness is present

irritation develops

symptoms persist for more than 7 days or clear up and occur again within few days

signs of skin injury, such as pain, swelling, or blistering where the product was applied

Flammable keep away from fire or flame

If pregnant or breast-feeding ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

Adults and Children over 12 years:

apply to affected area

massage into painful area until thoroughly absorbed into skin

repeat as necessary, but no more than 3 to 4 times daily

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

Children 12 years or younger: ask a doctor

Acrylates/c10-30 alkyl acrylate crosspolymer, capsaicin, glycerin, isopropyl myristate, propylene glycol, SD alcohol 40 (30%), triethanolamine, water (245-256)

Distributed By:

Universal Distribution Center

Edison, NJ 08854

www.universaldc.com

82720

Made in P.R.C.

MEDICATED NO MESS APPLICATOR 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71183-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.16 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAPSAICIN (UNII: S07O44R1ZM)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71183-029-25	73 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/30/2017	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/30/2017	01/01/2019

Labeler - Essentials Biotech Co, Ltd (544530742)

Revised: 10/2019

Document Id: 96400fd7-0edb-4115-e053-2a95a90a5b3c

34390-5

Set id: 5fdc667d-c29a-6644-e053-2a91aa0ad55d

Version: 4

Effective Time: 20191031