24909-199 terrasil Back Pain Cream

Terrasil Back Pain Cream by

Drug Labeling and Warnings

Terrasil Back Pain Cream by is a Otc medication manufactured, distributed, or labeled by Aidance Skincare & Topical Solutions, LLC, Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TERRASIL BACK PAIN CREAM- menthol cream 
Aidance Skincare & Topical Solutions, LLC

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24909-199 terrasil Back Pain Cream

Active Ingredients

Menthol 4%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with simple back ache.

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

TERRASIL BACK PAIN CREAM 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-199
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-199-01	44 g in 1 JAR; Type 0: Not a Combination Product	07/28/2021	01/20/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/28/2021	01/20/2025

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

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions		018950611	manufacture(24909-199) , label(24909-199)

Revised: 5/2024

Document Id: 193cf31e-6afc-4823-e063-6394a90a49b7

34390-5

Set id: 8c3b41ea-6466-4193-8121-709cb5feb2f6

Version: 2

Effective Time: 20240524

 

Aidan