TERRASIL FLEX PAIN RELIEF AND MUSCLE RUB- 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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Terrasil FLEX Pain Relief & Muscle Rub

Active ingredient and purpose: Menthol 4% (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

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

Terrasil

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

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

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