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Product NDC Code | 79804-260 | ||||
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Drug Name | Pain cream |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 2610119 | ||||
Application Number | M017 | ||||
Labeler Name | Eagle Labs Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 6% Camphor 5% Purpose Topical Analgesic
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 over 12 years old: Apply to affected area - do not apply more than 4 times adaily: Children 12 years or younger: Consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Bis-Vinyl Dimethicone/Dimthicone Copolymer, C13-C14 Isoparaffin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycol Stearate, Jojoba Oil, Laureth-7, Lavender Oil, Phenoxyethanol, Polyarylamide, Shea Butter, Simethicone, Sodium Acrylate/Sodium Acrylol Dimethyl Taurate Copolymer, Spearmint Oil, Water.
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.Uses: For Temporary relief of aches and pains of muscles and joints associated with arthritis, bachaches, strains, or sprains.
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Pain Cream Analgesic MENTHOL MENTHOL CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMER CAPRYLIC/CAPRIC ACID WATER CETYL ALCOHOL SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) PHENOXYETHANOL SHEA BUTTER SILICON DIOXIDE CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) LAURETH-7 LAVENDER OIL SPEARMINT OIL C13-14 ISOPARAFFIN DIMETHICONE GLYCOL STEARATE JOJOBA OIL
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.INSTA EAZE: RUB THE PAIN AWAY Insta Eaze Rub The Pain Away
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 ingested, get medical help, or contact poison control center immediately: 1-800-222-1222
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop Usage immediately and as a doctor if: Condition worsens or symptoms persist for more than 7 days.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.WHEN USING THIS PRODUCT Use only as directed: Avoid contact with eyes or mucous membranes: Do not apply directly to wounds or damaged skin: Do no use in combination with other ointments, creams, or sprays: Wash hands with cool water after each use: Do not sue with a heat pad or device.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding: Ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Other Information Flammable: Keep away from excessive heat or open flame. Keep out of direct sunlight: Store at 50-86F (15-30C)
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: For external use only. Do not use if safety seal is damaged or missing.
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