TERRASIL FLEX PAIN RELIEF AND MUSCLE RUB- menthol cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient and purpose: Menthol 4% (Topical Analgesic)

PURPOSE

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

Purified water, emulsifying wax, shea butter, cotton seed oil, sorbic acid (preservative), chamomile oil, jojoba oil, sage oil, vitamin B oil, olive oil, vegetable stearic acid (naturally sourced), magnesium oxide, silver oxide, zinc oxide

PRINCIPAL DISPLAY PANEL 

Natural
terrasil® FLEX
PAIN RELIEF & MUSCLE RUB CREAM

For Arthritis, Sore Muscles, Joint & Back Pain

INGREDIENTS AND APPEARANCE

TERRASIL FLEX PAIN RELIEF AND MUSCLE RUB 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-191
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL STEARATE (UNII: 06RI5UQA7L)
SHEA BUTTER (UNII: K49155WL9Y)
COTTONSEED OIL (UNII: H3E878020N)
SORBIC ACID (UNII: X045WJ989B)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
JOJOBA OIL (UNII: 724GKU717M)
SAGE OIL (UNII: U27K0H1H2O)
PANTHENOL (UNII: WV9CM0O67Z)
OLIVE OIL (UNII: 6UYK2W1W1E)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
SILVER OXIDE (UNII: 897WUN6G6T)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-191-44	44 g in 1 JAR; Type 0: Not a Combination Product	08/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/06/2019

Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-191) , label(24909-191)