MediRelief Hot: Package Insert and Label Information

MEDIRELIEF HOT- capsaicin patch
Farla Medical

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.

Drug Facts

Active ingredient & Purpose

Active ingredients (in each patch)	Purpose
Capsaicin 0.025%……………………………………………………………………………………………………………………………………..	Topical analgesic

Uses

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

• simple back aches
• arthritis
• strains
• sprains

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with the eyes.

Do not use

• on wounds or damaged skin
• on a tight bandage
• with a heating pad
• on sensitive skin
• if allergic to any ingredients in this product

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

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

Directions

• adults & 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 doctor

Other information

• store at room temperature 68-77°F (20-25°C)
• do not store in direct sunlight or expose to excessive heat and moisture

TAMPER EVIDENT: Do not use if pouch containing the patch is torn or broken.

Inactive ingredients

hydrogenated poly (C6-20 olefin), mineral oil, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, styrene/isoprene copolymer

Manufactured for & Distributed by:

Manufactured for:

Farla International Ltd., Unit 2,

Staples Corner Business Park, 1000 North Circular Road,

London NW2 7JP

Tel +1 (844) 280-8400

sales@farlainternational.com — www.farlainternational.com

Distributed by:

Platinum Care

240 52nd Street, Brooklyn, NY 11220

Tel: +1-718-435-2072

Pricipal Display Panel

MediRelief a Farla brand

Hot

Penetrating Pain

Relief Patch

Capsaicin 0.025%

TEMPORARY RELIEF OF

MINOR ACHES AND PAINS:

• ARTHRITIS

• BACKACHES

• SPRAINS

• STRAINS

1 Patch

(Large)

5.1 in. x 7.1 in.

(13 cm x 18 cm)

MEDIRELIEF HOT capsaicin patch

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73486-100 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (CAPSAICIN) CAPSAICIN 0.25 mg

Inactive Ingredients Ingredient Name Strength HYDROGENATED C6-20 POLYOLEFIN (100 CST) PENTAERYTHRITOL 3,5-DI-TERT-BUTYL-4-HYDROXYHYDROCINNAMATE MINERAL OIL STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73486-100-35 5 POUCH in 1 BOX contains a POUCH 1 1 PATCH in 1 POUCH This package is contained within the BOX (73486-100-35)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/31/2020

Labeler — Farla Medical (221985675)

Revised: 05/2020 Farla Medical