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Product NDC Code | 83033-1602 | ||||
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Drug Name | Rayo power ice heat dual action |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
Application Number | M017 | ||||
Labeler Name | Quimicas Handal de Centroamerica SA de CV | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Mentol, Camphor (synthetic)
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.Directions Adults and children 2 years of age and older: Rub a thick layer well over throat and chest Use 3 to 4 times daily Keep clothes loose about throat and chest to help vapors reach nose and mouth For muscle and joint minor aches apply to affected area no more than 3 to 4 times daily Children under 2 years: do not use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.T
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 Adults and children 2 years of age and older: Rub a thick layer well over throat and chest Use 3 to 4 times daily Keep clothes loose about throat and chest to help vapors reach nose and mouth For muscle and joint minor aches apply to affected area no more than 3 to 4 times daily Children under 2 years: do not use.
Purpose
Information about the drug product’s indications for use.When applied to chest and throat, temporarily relieves cough due to minor throat and bronchial irritation associated with common cold.
Spl product data elements
Usually a list of ingredients in a drug product.RAYO ACTIVE HEAT MENTHOL, METHYL SALICYLATE MICROCRYSTALLINE WAX WATER MINERAL OIL CETYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER MENTHOL MENTHOL METHYLISOTHIAZOLINONE METHYL SALICYLATE SALICYLIC ACID RAYO ACTIVE HEAT MENTHOL, METHYL SALICYLATE MICROCRYSTALLINE WAX WATER MINERAL OIL CETYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER MENTHOL MENTHOL METHYLISOTHIAZOLINONE METHYL SALICYLATE SALICYLIC ACID RAYO ACTIVE HEAT MENTHOL, METHYL SALICYLATE MICROCRYSTALLINE WAX WATER MINERAL OIL CETYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER MENTHOL MENTHOL METHYLISOTHIAZOLINONE METHYL SALICYLATE SALICYLIC ACID RAYO ACTIVE ICE MENTHOL, CAMPHOR POLYSORBATE 80 WATER TROLAMINE ISOPROPYL ALCOHOL FD&C BLUE NO. 1 MENTHOL MENTHOL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE METHYLISOTHIAZOLINONE RAYO BREATH CHAMOMILE MENTHOL, CAMPHOR MENTHOL MENTHOL TURPENTINE EUCALYPTOL PETROLATUM CHAMOMILE CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) RAYO ACTIVE ICE MENTHOL, CAMPHOR POLYSORBATE 80 WATER TROLAMINE ISOPROPYL ALCOHOL FD&C BLUE NO. 1 MENTHOL MENTHOL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE METHYLISOTHIAZOLINONE RAYO BREATH MENTHOL MENTHOL, CAMPHOR MENTHOL MENTHOL TURPENTINE EUCALYPTOL PETROLATUM CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) RAYO BREATH MENTHOL MENTHOL, CAMPHOR MENTHOL MENTHOL TURPENTINE EUCALYPTOL PETROLATUM CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) RAYO BREATH CHAMOMILE MENTHOL, CAMPHOR TURPENTINE MENTHOL MENTHOL EUCALYPTOL PETROLATUM CHAMOMILE CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) RAYO POWER ICE HEAT DUAL ACTION MENTHOL POLYSORBATE 80 WATER TROLAMINE ISOPROPYL ALCOHOL MENTHOL MENTHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE METHYLISOTHIAZOLINONE RAYO BREATH CHAMOMILE MENTHOL, CAMPHOR MENTHOL MENTHOL TURPENTINE EUCALYPTOL PETROLATUM CHAMOMILE CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) RAYO ACTIVE ICE SACHET MENTHOL, CAMPHOR POLYSORBATE 80 WATER TROLAMINE ISOPROPYL ALCOHOL FD&C BLUE NO. 1 MENTHOL MENTHOL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE METHYLISOTHIAZOLINONE RAYO ACTIVE HEAT MENTHOL, METHYL SALICYLATE MICROCRYSTALLINE WAX WATER MINERAL OIL CETYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER MENTHOL MENTHOL METHYLISOTHIAZOLINONE METHYL SALICYLATE SALICYLIC ACID RAYO ACTIVE ICE MENTHOL, CAMPHOR POLYSORBATE 80 WATER TROLAMINE ISOPROPYL ALCOHOL FD&C BLUE NO. 1 MENTHOL MENTHOL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE METHYLISOTHIAZOLINONE
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.1620 1620
1595 Principal
1606 Principal
1594 Principal
1602 Principal
1600 Principal
1598 Principal
1612 Principal
1609 Principal
1610 Principal
1605 Principal
1611 Principal
1599 Principal
1601 Principal
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.Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.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.For external use only; avoid contact with eyes Ask a doctor before if you have: sensitive skin Do not use by mouth in nostrils on wounds or damaged skin When using this product Avoid contact with the ayes or muccus membranes Wash hands after use with cool water Do not microwave Stop use and ask a doctor if: Cough occurs with too much mucus (phlegm), or if symptoms persist for more than 7 days or clear up and occur again within a few days.
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