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

2
(click image for full-size original)

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

Sore No More Packaging
(click image for full-size original)

Inflatherm Packaging

The packaging for Inflatherm is shown below

Inflatherm Packaging
(click image for full-size original)
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 relabel (72835-701)

Revised: 01/2022 V2 Pharma, LLC

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