FORS PAIN RELIEF by FORS LLC FORS PAIN RELIEF CREAM

Drug Details [pdf]

FORS PAIN RELIEF- menthol, capsaicin cream
FORS 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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FORS PAIN RELIEF CREAM

Drug Facts

Active Ingredients

Menthol 4.00%

Capsaicin 0.035%

Purpose

Topical Analgesic

Uses:

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

Warnings:

For external use only

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.
Do not bandage tightly.

Stop use and ask a doctor if

rash or irritation develops and lasts.
Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

If swallowed, get medical help or contact a Poision Control Center right away.

If pregnant or breast-feeding,

ask a health professional before use.

Directions:

Adults and children 2 years of age and older: Apply to affected area not ore than 3 to 4 times daily.
Children under 2 years of age: consult doctor.

Other information:

Store at 20-25 C (68-77 F) and protect from moisture.

Inactive Ingredients:

Acrylates/C10-30 Alky Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf(Aloe Vera Gel) Juice, Aqua (Deionized Water), Amica Montana Flower Extract, Boswellia Serrata Extract, Butylene Glycol, *Cannabidiol (CBD), Caprylic/Capric Triglyceride, Celeareth-20, Cetyl Alcohol, Ethylhexyglycerin, Eucalyptus Globulus Oil, Glycerin, Clyceryl Stearate,Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurale Copolymer, Ilex
Paraguayensis (Yerba Mate) Extract, Methylsulfonylmethane (MSM), Mineral Oil, Phenoxyethanol, Polysorbate-20, Polysorbate-60, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Squalane Stearic Acid, Triethanolamine, Tocopheryl Acetate (Vitamin E).

Questions?

1-800-210-7924

Package Labeling:

Label

FORS PAIN RELIEF
menthol, capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81765-184
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg in 1 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.35 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CANNABIDIOL (UNII: 19GBJ60SN5)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
MINERAL OIL (UNII: T5L8T28FGP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ALMOND OIL (UNII: 66YXD4DKO9)
SQUALANE (UNII: GW89575KF9)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 81765-184-01	1 in 1 BOX	04/05/2021	03/31/2023
1		60 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/05/2021	03/31/2023

Labeler - FORS LLC (117722650)

Revised: 1/2022

Document Id: d597f26b-a675-5fb1-e053-2995a90a4f2f

Set id: f4959721-dc6b-4f83-80ec-4f285eaa4835

Version: 2

Effective Time: 20220114