THERALAST TOPICAL ANALGESIC RELIEF- 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 Topical Analgesic Relief 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:

  • simple backache
  • strains
  • sprains
  • bruises
  • arthritis

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

  • Use only as directed
  • Adults and children over 12 years: apply to affected area not more than 4 times daily.
  • Children under 12 years of age: Consult physician.

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

TOPICAL ANALGESIC

RELIEF

GEL

LASTS UP TO 8 HOURS

FAST ACTING

DEEP PENETRATING

NON-GREASY APPLICATION

PHYSICIAN

RECOMMENDED

PATIENT

APPROVED

TERANONA®

MOLECULAR TECHNOLOGY

3.4 FL OZ (100 ML)

Performance claims based on patient surveys

theralast

THERALAST TOPICAL ANALGESIC RELIEF 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80967-001
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:80967-001-011 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 finalpart34811/15/202010/31/2022
Labeler - SKIN SHERPA NORTH AMERICA LLC (117719003)

Revised: 2/2022
Document Id: d8b2417c-5d4f-8e48-e053-2a95a90abe6d
Set id: b42da9ec-fefd-bb40-e053-2a95a90aff87
Version: 3
Effective Time: 20220223
 
SKIN SHERPA NORTH AMERICA LLC