DIRT PAIN RELIEVING GEL- menthol gel 
PURIVITAE, LLC

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DIRT Pain Relieving Gel

Drug Facts

Active Ingredients:

Menthol 4%

Purpose

Topical Analgesic

Uses:

For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, simple back aches, strains, bruises, and sprains.

Warnings:

For external use only

Do not use

  • on damaged or broken skin

When using this product

  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

If pregnant or breast-feeding,

ask a health professional before use

Directions:

Adults and children over 12 years of age:

ask a doctor Children 12 years or younger:

Inactive Ingredients:

Activated Charcoal, Acrylates/Cl0-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Amica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, llex Paraguariensis (Verba Mate') Extract, Melaleuca Alternilolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Propylene Glycol, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E), Triethanolamine.

Package Labeliing:

Label

DIRT PAIN RELIEVING GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83067-463
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
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
TEA TREE OIL (UNII: VIF565UC2G)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83067-463-0088 mL in 1 BOTTLE; Type 0: Not a Combination Product10/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/03/2023
Labeler - PURIVITAE, LLC (086896991)

Revised: 11/2023
Document Id: 097705c5-f169-19a5-e063-6294a90acfaf
Set id: e43e2cbd-d114-4b11-8baf-7a775881cd97
Version: 2
Effective Time: 20231106
 
PURIVITAE, LLC