TERRASIL JOINT PAIN CREAM- menthol cream 
Aidance Skincare & Topical Solutions, 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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Drug Facts

Active Ingredients

Menthol 4%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with strains.

Warnings

For external use only.
Do not use on wounds or damaged skin and avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Keep out of reach of children.

If swallowed consult a physician.

Directions

Adults and children 12 years of age and older. Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age - consult a physician. May stain fabrics.

Inactive Ingredients

Chamomile oil, cotton seed oil, emulsifying wax, jojoba oil, magnesium oxide, olive oil, purified water, sage oil, shea butter, silver stearate, sorbic acid (preservative), vitamin B oil, zinc oxide.

401-432-7750 or www.aidance.com

Product label

image description

TERRASIL JOINT PAIN CREAM 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-198
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COTTONSEED OIL (UNII: H3E878020N)  
JOJOBA OIL (UNII: 724GKU717M)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
WATER (UNII: 059QF0KO0R)  
SAGE OIL (UNII: U27K0H1H2O)  
SHEA BUTTER (UNII: K49155WL9Y)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
SORBIC ACID (UNII: X045WJ989B)  
SILVER OXIDE (UNII: 897WUN6G6T)  
PANTHENOL (UNII: WV9CM0O67Z)  
CETYL STEARATE (UNII: 06RI5UQA7L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-198-0144 g in 1 JAR; Type 0: Not a Combination Product07/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/28/2021
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions018950611manufacture(24909-198) , label(24909-198)

Revised: 8/2021
Document Id: c93ac12a-ec56-663a-e053-2995a90ad082
Set id: 776776d0-e355-4b40-a5d3-8962434105d8
Version: 1
Effective Time: 20210810
 
Aidance Skincare & Topical Solutions, LLC