MD80 CLINICAL STRENGTH TOPICAL ANALGESIC- menthol gel 
SKIN SHERPA NORTH AMERICA 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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MD80 CLINICAL STRENGTH TOPICAL ANALGESIC GEL

Drug Facts

Active ingredient

Menthol 4%

Purpose

Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

Warnings

For external use only.

Do not use

  • on large areas of the body
  • with other ointments, creams, sprays or liniments
  • with heating pad

Ask a doctor before use if you have

sensitive skin or redness over the affected area

When using this product

  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage
  • wash hands after use

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children.

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

Directions

Other information

Store in cool dry place

Inactive ingredients

Alcohol Denat., Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Butylene Glycol, Diethyl Nonanedioate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isopropyl Alcohol, Methyl Hydroxypropyl Cellulose, Polyacrylate Crosspolymer 6, Polysorbate 20, Water

Questions?

1-806-319-8845 or md80relief.com

Company Information

Distributed by Skin Sherpa North America, LLC, 18756 Stone Oak Pkwy, Ste. 200 San Antonio, TX 78258

www.md80relief.com

Product Packaging

md80

MD80 CLINICAL STRENGTH TOPICAL ANALGESIC 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80967-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
ALCOHOL (UNII: 3K9958V90M)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
DIETHYL AZELATE (UNII: 4E9QQ39A4X)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80967-004-011 in 1 BOX05/02/2022
1100 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:80967-004-033 in 1 BOX05/02/2022
23 mL in 1 PACKET; Type 0: Not a Combination Product
3NDC:80967-004-1010 in 1 BOX05/02/2022
33 mL in 1 PACKET; Type 0: Not a Combination Product
4NDC:80967-004-2020 in 1 BOX05/02/2022
43 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/02/2022
Labeler - SKIN SHERPA NORTH AMERICA LLC (117719003)

Revised: 5/2022
Document Id: de0da4fa-803c-1532-e053-2995a90afbd4
Set id: de0da4fa-803d-1532-e053-2995a90afbd4
Version: 1
Effective Time: 20220502
 
SKIN SHERPA NORTH AMERICA LLC