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NDC 24909-0199-01 Terrasil Back Pain Cream 4 g/100g Details

Terrasil Back Pain Cream 4 g/100g

Terrasil Back Pain Cream is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Aidance Skincare & Topical Solutions, LLC. The primary component is MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	24909-0199
Product ID	24909-199_c93a9537-1231-c97c-e053-2a95a90a9fe6
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Terrasil Back Pain Cream
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	4
Active Ingredient Units	g/100g
Substance Name	MENTHOL, UNSPECIFIED FORM
Labeler Name	Aidance Skincare & Topical Solutions, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 24909-0199-01 (24909019901)

Pricing Information	N/A
NDC Package Code	24909-199-01
Billing NDC	24909019901
Package	44 g in 1 JAR (24909-199-01)
Marketing Start Date	2021-07-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8c3b41ea-6466-4193-8121-709cb5feb2f6 Details

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.

SPL UNCLASSIFIED SECTION

401-432-7750 or www.aidance.com

Product label

INGREDIENTS AND APPEARANCE

TERRASIL BACK PAIN CREAM

menthol cream

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24909-199-01	44 g in 1 JAR; Type 0: Not a Combination Product	07/28/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/28/2021

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

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

Revised: 8/2021

Document Id: c93a9537-1231-c97c-e053-2a95a90a9fe6

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

Version: 1

Effective Time: 20210810