TERRASIL FLEX -PAIN RELIEF AND MUSCLE RUB MAX- menthol ointment 
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.

----------

Terrasil FLEX MAX Pain Relief & Muscle Rub

Active ingredient and purpose: Menthol 8% (Topical Analgesic)

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with simple backaches, arthritis, strains and bruises.

Warnings

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

Keep out of reach of children. If swallowed, consult a physician.

Directions

Adults & 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.

Inactive Ingredients

Cotton seed oil, beeswax, sorbic acid (preservative), arnica oil, chamomile oil, jojoba seed oil, sage oil, olive oil, vegetable stearic acid (naturally sourced), magnesium oxide, silver oxide, zinc oxide

PRINCIPAL DISPLAY PANEL 

Natural
terrasil® FLEX MAX
PAIN RELIEF & MUSCLE RUB OINTMENT

For Arthritis, Sore Muscles, Joint & Back Pain

Terrasil

TERRASIL FLEX -PAIN RELIEF AND MUSCLE RUB MAX 
menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-192
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COTTONSEED OIL (UNII: H3E878020N)  
WHITE WAX (UNII: 7G1J5DA97F)  
SORBIC ACID (UNII: X045WJ989B)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
JOJOBA OIL (UNII: 724GKU717M)  
SAGE OIL (UNII: U27K0H1H2O)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
SILVER OXIDE (UNII: 897WUN6G6T)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-192-4444 g in 1 JAR; Type 0: Not a Combination Product08/06/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/06/2019
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-192) , label(24909-192)

Revised: 7/2019
Document Id: 20dde967-de8f-4119-a17b-ecf9877fc8ef
Set id: 4720eb64-b7c7-4136-a2e6-0f280c7a0109
Version: 1
Effective Time: 20190722
 
Aidance Skincare & Topical Solutions, LLC