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| Product NDC Code | 52000-421 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Cold and hot medicated large |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | PATCH | ||||||
| RxCUI drug identifier | 420222 | ||||||
| Application Number | M017 | ||||||
| Labeler Name | UNIVERSAL DISTRIBUTION CENTER, LLC | ||||||
| Packages |
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Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Uses Topical Analgesic Temporarily relieve minor aches and pains of muscles and joints due to Simple Backache Arthritis Muscle Strains Bursitis Tendonitis Muscle Sprains Bruises Cramps
Uses Topical Analgesic Temporarily relieve minor aches and pains of muscles and joints due to Simple Backache Arthritis Muscle Strains Bursitis Tendonitis Muscle Sprains Bruises Cramps
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80
Inactive Ingredients Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Directions DIRECTIONS Adults and Children 12 years of age and older: Peel off protective backing and apply sticky side to affected area. Carefully remove backing from patch Should be used up to 8 hours Should be used no more than 3 to 4 times daily Children under 12 years of age: Consult a doctor.
Directions DIRECTIONS Adults and Children 12 years of age and older: Peel off protective backing and apply sticky side to affected area. Carefully remove backing from patch Should be used up to 8 hours Should be used no more than 3 to 4 times daily Children under 12 years of age: Consult a doctor.
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.COLD AND HOT MEDICATED LARGE Menthol POLYSORBATE 80 ALCOHOL 95% WATER TARTARIC ACID DMDM HYDANTOIN KAOLIN POVIDONE K90 DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS GLYCERIN EDETATE DISODIUM CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SODIUM POLYACRYLATE (2500000 MW) MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.5% Menthol Pain Relief Patch (1 Large Patch / Pouch ) NDC: 52000-421-41 5% Menthol Pain Relief Patch (1 Large Patch/Pouch) NDC: 84205-008-00 Uses Topical Analgesic Temporarily relieve minor aches and pains of muscles and joints due to Simple Backache Arthritis Muscle Strains Bursitis Tendonitis Muscle Sprains Bruises Cramps Warnings WARNINGS: EXTERNAL USE ONLY When using this product USE ONLY AS DIRECTED do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged skin. 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 redness is present skin irritation develops 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 (1-800-222-1222) immediatedly. Inactive Ingredients Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80 Directions DIRECTIONS Adults and Children 12 years of age and older: Peel off protective backing and apply sticky side to affected area. Carefully remove backing from patch Should be used up to 8 hours Should be used no more than 3 to 4 times daily Children under 12 years of age: Consult a doctor. Purpose Topical Analgesic Warnings KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediatedly.
5% Menthol Pain Relief Patch (24 Pouches / Box) NDC: 52000-421-42 5% Menthol Pain Relief Patch (1 Large Patch X 24Patches) NDC: 84205-008-01 Uses Topical Analgesic Temporarily relieve minor aches and pains of muscles and joints due to Simple Backache Arthritis Muscle Strains Bursitis Tendonitis Muscle Sprains Bruises Cramps Warnings WARNINGS: EXTERNAL USE ONLY When using this product USE ONLY AS DIRECTED do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged skin. 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 redness is present skin irritation develops 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 (1-800-222-1222) immediatedly. Inactive Ingredients Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80 Directions DIRECTIONS Adults and Children 12 years of age and older: Peel off protective backing and apply sticky side to affected area. Carefully remove backing from patch Should be used up to 8 hours Should be used no more than 3 to 4 times daily Children under 12 years of age: Consult a doctor. Purpose Topical Analgesic Warnings KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediatedly.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Warnings KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediatedly.
Warnings KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediatedly.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings WARNINGS: EXTERNAL USE ONLY When using this product USE ONLY AS DIRECTED do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged skin. 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 redness is present skin irritation develops 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 (1-800-222-1222) immediatedly.
Warnings WARNINGS: EXTERNAL USE ONLY When using this product USE ONLY AS DIRECTED do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged skin. 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 redness is present skin irritation develops 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 (1-800-222-1222) immediatedly.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API