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| Product NDC Code | 52000-040 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Capsaicin heat |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | PATCH | ||||||
| RxCUI drug identifier | 1043399 | ||||||
| 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 For temporary relief of minor aches and pains of muscles & joints associated with: Simple Backache Arthritis Strains Bruises Sprains
Uses Topical Analgesic For temporary relief of minor aches and pains of muscles & joints associated with: Simple Backache Arthritis Strains Bruises Sprains
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Propylene Glycol, Polysorbate 80, Carboxymethylcellulose Sodium, Carbomer, Purified Water, POVIDONE K90, Tartaric Acid, DMDM Hydantoin
Inactive Ingredients Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Propylene Glycol, Polysorbate 80, Carboxymethylcellulose Sodium, Carbomer, Purified Water, POVIDONE K90, Tartaric Acid, DMDM Hydantoin
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: Clean and dry affected area Remove patch from film Apply to affected area not more than 3 to 4 times daily Remove patch from skin after at most 8 hours of application Children under 12 years of age: Consult a doctor.
Directions DIRECTIONS Adults and Children 12 years of age and older: Clean and dry affected area Remove patch from film Apply to affected area not more than 3 to 4 times daily Remove patch from skin after at most 8 hours of application 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.Capsaicin Heat capsaicin SODIUM POLYACRYLATE (2500000 MW) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) GLYCERIN DMDM HYDANTOIN PROPYLENE GLYCOL CAPSAICIN CAPSAICIN KAOLIN EDETATE DISODIUM POVIDONE K90 TARTARIC ACID WATER POLYSORBATE 80 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS
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.CAPSAICIN HEAT capsaicin patch NDC: 52000-040-42 CAPSAICIN HEAT capsaicin patch NDC: 52000-040-42 Uses Topical Analgesic For temporary relief of minor aches and pains of muscles & joints associated with: Simple Backache Arthritis Strains Bruises Sprains Warnings WARNINGS: EXTERNAL USE ONLY DO NOT USE on wounds or damaged skin with a heating pad with or at the same times as other external analgesic if you are allergic to any ingredients of this product When using this product do not use otherwise than as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly discountinue use at least 1 hour before a bath or shower do not use immediately after a bath or shower STOP USE and ask a doctor if rash, itching or excessive skin irritation develops conditions worsen symptoms persist for more than 7 days symptoms clear up and occur again with 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 (1-800-222-1222) immediatedly. Inactive Ingredients Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Propylene Glycol, Polysorbate 80, Carboxymethylcellulose Sodium, Carbomer, Purified Water, POVIDONE K90, Tartaric Acid, DMDM Hydantoin Directions DIRECTIONS Adults and Children 12 years of age and older: Clean and dry affected area Remove patch from film Apply to affected area not more than 3 to 4 times daily Remove patch from skin after at most 8 hours of application 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. Compare to the active ingredient in Salonpas® - Hot Capsicum Patch® *This product is NOT manufactured or distributed by Hisamitsu®, owner of Salonpas® Hot Capsicum Patch. Distributed by: Universal Distribution Center 96 Distribution Boulevard • Edison, NJ 08817 Made in P.R.C.
CAPSAICIN HEAT capsaicin patch NDC: 52000-040-43 CAPSAICIN HEAT capsaicin patch NDC: 52000-040-43 Uses Topical Analgesic For temporary relief of minor aches and pains of muscles & joints associated with: Simple Backache Arthritis Strains Bruises Sprains Warnings WARNINGS: EXTERNAL USE ONLY DO NOT USE on wounds or damaged skin with a heating pad with or at the same times as other external analgesic if you are allergic to any ingredients of this product When using this product do not use otherwise than as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly discountinue use at least 1 hour before a bath or shower do not use immediately after a bath or shower STOP USE and ask a doctor if rash, itching or excessive skin irritation develops conditions worsen symptoms persist for more than 7 days symptoms clear up and occur again with 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 (1-800-222-1222) immediatedly. Inactive Ingredients Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Propylene Glycol, Polysorbate 80, Carboxymethylcellulose Sodium, Carbomer, Purified Water, POVIDONE K90, Tartaric Acid, DMDM Hydantoin Directions DIRECTIONS Adults and Children 12 years of age and older: Clean and dry affected area Remove patch from film Apply to affected area not more than 3 to 4 times daily Remove patch from skin after at most 8 hours of application 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. Compare to the active ingredient in Salonpas® - Hot Capsicum Patch® *This product is NOT manufactured or distributed by Hisamitsu®, owner of Salonpas® Hot Capsicum Patch. Distributed by: Universal Distribution Center 96 Distribution Boulevard • Edison, NJ 08817 Made in P.R.C.
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 DO NOT USE on wounds or damaged skin with a heating pad with or at the same times as other external analgesic if you are allergic to any ingredients of this product When using this product do not use otherwise than as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly discountinue use at least 1 hour before a bath or shower do not use immediately after a bath or shower STOP USE and ask a doctor if rash, itching or excessive skin irritation develops conditions worsen symptoms persist for more than 7 days symptoms clear up and occur again with 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 (1-800-222-1222) immediatedly.
Warnings WARNINGS: EXTERNAL USE ONLY DO NOT USE on wounds or damaged skin with a heating pad with or at the same times as other external analgesic if you are allergic to any ingredients of this product When using this product do not use otherwise than as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly discountinue use at least 1 hour before a bath or shower do not use immediately after a bath or shower STOP USE and ask a doctor if rash, itching or excessive skin irritation develops conditions worsen symptoms persist for more than 7 days symptoms clear up and occur again with 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 (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