REVLEX ARTHRITIS PAIN RELIEF- capsaicin solution 
Cura Health Inc.

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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Drug Facts

Active Ingredients

Capsaicin 0.25%

Purpose

Topical Analgesic

Use:

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis.

Warnings

Do not

  • Apply to wounds or damaged skin.
  • Bandage tightly.
  • Inhale.
  • Apply with external heat, such as an electric pad, as this may result in excessive skin irritation or skin burn.

When using this product

  • Use only as directed.

  • Keep out of reach of children. If overdose or accidental ingestion occurs, call a poison control center immediately.
  • Consult a healthcare practitioner prior to use if you are pregnant or breastfeeding.

Stop use and ask a doctor if you experience hypersensitivity, rashes and/or burning discomfort, headache or redness or if symptoms worsen or re-occur with a few days.

Directions

Avoid taking a hot bath or shower just before or after applications as a burning sensation may result.

Product can be rinsed off with cool water and soap.

Inactive Ingredients

Aqua water/eau, Alcohol, BHT, Propylene glycol, Phosphatidylcholine, Polysorbate 20, Sodium Metabisulfate

Questions or Comments?

1-844-5REVLEX (573-8539)

INFORMATIONS SUR LE PRODUIT

Ingrédient Actif

Capsaïcin 0.25%

Fonction

Analgésique Topique

Usage: Soulage temporairement la douler et les courbatures des muscles et des articulations associées á la douler arthritique.

Avertissements

Ne pas

Lors de l'utilisation de ce produit,

Cesser l'utilisation et demander l'avis d'un médecin en cas d'hypersensibilité, de démangeaisons et/ou de sensation de brûlure, de maux de tête ou de rougeurs, ou si les symptômes s'aggravent ou réapparaissent aprés quelques jours.

Mode d'Emploi

Éviter de prendre un bain chaud ou une douche juste avant ou aprés l'application, une sensation de brûlure pourrat survenir. Le produit peut être rincé avec de l'eau froide et du savon.

Ingrédients Inactifs

Aqua/water/eau, Alcohol, BHT, Propylene glycol, Phosphatidylcholine, Polysorbate 20, Sodium Metabisulfite

Questions?

1-844-5REVLEX (573-8539)

Principal Display Panel - Revlex Arthritis Pain Relief 15 mL Carton Label

ODOURLESS ROLL-ON

10X

REGULAR
STRENGTH

REVLEX™

ARTHRITIS PAIN
RELIEF

CAPSAICIN 0.25%

NATURALLY ACTING

QUICK RELIEF

In support of

The Arthritis
Society

15 mL

NPN 80054638

Figure

Principal Display Panel - Revlex Arthritis Pain Relief 45 mL Carton Label

ODOURLESS ROLL-ON

10X

REGULAR
STRENGTH

REVLEX™

ARTHRITIS PAIN
RELIEF

CAPSAICIN 0.25%

NATURALLY ACTING

QUICK RELIEF

In support of

The Arthritis
Society

45 mL

NPN 80054638

Figure
REVLEX ARTHRITIS PAIN RELIEF 
capsaicin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72128-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Alcohol (UNII: 3K9958V90M)  
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Carboxymethylcellulose Sodium (UNII: K679OBS311)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Lecithin, Soybean (UNII: 1DI56QDM62)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72128-001-151 in 1 BOX05/01/2018
115 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2NDC:72128-001-451 in 1 BOX05/01/2018
245 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2018
Labeler - Cura Health Inc. (243201991)
Establishment
NameAddressID/FEIBusiness Operations
Entreprises Importfab Inc.248586117MANUFACTURE(72128-001, 72128-001)

Revised: 4/2018
Document Id: 89e4716e-3682-41a5-9e3d-454c3c33f8f0
Set id: 4cbebf3f-0752-4e18-89ea-4f0f518ed07b
Version: 1
Effective Time: 20180423
 
Cura Health Inc.