PAIN RELEASE JOINT AND ARTHRITIS CREAM- menthol cream

Pain Release Joint and Arthritis Cream by

Drug Labeling and Warnings

Pain Release Joint and Arthritis Cream by is a Otc medication manufactured, distributed, or labeled by Saje Natural Business Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 2.667%

PURPOSE

topical analgesic

INDICATIONS & USAGE

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

Directions For people aged 13 and above: Apply to affected area not more than 3-4 times daily.

STORAGE AND HANDLING

Store at room temperature and protect from light.

INACTIVE INGREDIENT

Inactive Ingredients Butyrospermum parkii (shea) butter, cetearyl alcohol, cetearyl olivate, copaifera officinalis (balsam copaiba) resin oil, glycerin, glyceryl caprylate, glyceryl undecylenate, origanum majorana (marjoram) leaf oil, pentylene glycol, phenethyl alcohol, propanediol, simmondsia chinensis (jojoba) seed oil, sorbitan olivate, stearic acid, theobroma cacao (cocoa) seed butter, water.

WARNINGS

Warnings
For external use only. Avoid contact with the eyes. Do not apply to wounds on damaged skin and bandage tightly. Discontinue use of this product and consult a doctor if condition worsens if symptoms persist for more than 7 days clear up and occur again within a few days.

Discontinue use of this product and consult a doctor if condition worsens if symptoms persist for more than 7 days clear up and occur again within a few days.

Do not apply to wounds on damaged skin and bandage tightly.

For external use only. Avoid contact with the eyes.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELEASE JOINT AND ARTHRITIS CREAM 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70983-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.667 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
PROPANEDIOL (UNII: 5965N8W85T)
SORBITAN OLIVATE (UNII: MDL271E3GR)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
COPAIFERA OFFICINALIS RESIN OIL (UNII: PZA3DGE9YF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70983-028-01	1 in 1 BOX	06/11/2024
1		75 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/11/2024

Labeler - Saje Natural Business Inc. (080465432)