Inflatherm (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0228-2551-06

Diclofenac Sodium Delayed-Release Tablets, USP

75 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Actavis

60 Enteric-Coated Tablets

Rx Only

Sore No More Warm Therapy

Active Ingredients

Menthol USP 3%, Camphor USP 3%

Purpose

Purpose
External Analgesic

Keep out of reach of children

Keep out of reach of children

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis, simple backaches

Warnings

For external use only. Do not use on wounds or damaged skin. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.

Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

Directions

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

Inactive Ingredients

aloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus aurantium dulcis (orange) peel oil, spiraea ulmaria flower (queen of the prairie) extract, rosa damascena flower water, sodium carbonate, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, phenoxyethanol, caprylyl glycol, capsicum annuum fruit extract

Questions or Comments

1-800-225-3963

Sore No More inner packaging

Inflatherm Packaging

The packaging for Inflatherm is shown below

INFLATHERM diclofenac sodium and menthol / camphor gel kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72835-701

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72835-701-02 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 60 Part 2 1 BOTTLE, PLASTIC 85 g

Part 1 of 2 DICLOFENAC SODIUM diclofenac sodium tablet, delayed release

Product Information Item Code (Source) NDC:0228-2551 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DICLOFENAC SODIUM (DICLOFENAC) DICLOFENAC SODIUM 75 mg

Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 PROPYLENE GLYCOL SILICON DIOXIDE SODIUM ALGINATE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID FERROSOFERRIC OXIDE TALC TITANIUM DIOXIDE Polyvinyl Acetate Phthalate ALUMINUM HYDROXIDE

Product Characteristics Color WHITE Score no score Shape ROUND Size 9mm Flavor Imprint Code R;551 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0228-2551-06 60 TABLET, DELAYED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074514

Part 2 of 2 SORE NO MORE WARM THERAPY menthol and camphor gel

Product Information Item Code (Source) NDC:61577-3234 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 0.03 g in 1 g CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 0.03 g in 1 g

Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF CARBOMER HOMOPOLYMER TYPE C DECYL GLUCOSIDE WATER CAPSAICIN GRAPEFRUIT SEED OIL GREEN TEA LEAF FILIPENDULA ULMARIA FLOWER ROSA CENTIFOLIA FLOWER OIL SODIUM CARBONATE GLYCERIN WITCH HAZEL YUCCA SCHIDIGERA ROOT ORANGE PEEL PHENOXYETHANOL CAPRYLYL GLYCOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:61577-3234-5 85 g in 1 BOTTLE, PLASTIC None

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

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074514 06/03/2019

Labeler — V2 Pharma, LLC (102457346)

Establishment
Name	Address	ID/FEI	Operations
Actavis Pharma, Inc.		079589880	label (0228-2551)

Establishment
Name	Address	ID/FEI	Operations
SOMBRA COSMETICS INC.		097464309	manufacture (61577-3234), label (61577-3234)

Establishment
Name	Address	ID/FEI	Operations
V2 Pharma, LLC		102457346	label (72835-701)

Revised: 02/2023 V2 Pharma, LLC