THERALAST CLINICAL STRENGTH MD3 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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Theralast Clinical Strength MD3 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 mucus 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, Hypromellose, Polysorbate 20, Water

Questions?

Call (210) 281-1056 MON-FRI 9AM-5PM CST

Company Information

Distributed by Skin Sherpa North America, LLC, San Antonio, TX 78216

Product Packaging

THERALAST

CLINICAL STRENGTH

MD3

TOPICAL ANALGESIC GEL

RELIEF UP TO 12 HOURS

FAST ACTING

DEEP PENETRATING

NON-GREASY APPLICATION

PHYSICIAN RECOMMENDED

TERANONA® MOLECULAR TECHNOLOGY

3.4 FL OZ (100 ML)

Performance claims based on patient surveys. theralast clinical

THERALAST CLINICAL STRENGTH MD3 TOPICAL ANALGESIC 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80967-002
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
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:80967-002-011 in 1 BOX11/15/2020
1100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/15/2020
Labeler - SKIN SHERPA NORTH AMERICA LLC (117719003)

Revised: 8/2021
Document Id: ca664c98-71cf-a86b-e053-2995a90ae655
Set id: b43a3167-a882-6b6d-e053-2a95a90a68ad
Version: 2
Effective Time: 20210825
 
SKIN SHERPA NORTH AMERICA LLC