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| Product NDC Code | 79804-618 | ||||
|---|---|---|---|---|---|
| Drug Name | Healthy back institute rub on relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1312283 | ||||
| Application Number | M017 | ||||
| Labeler Name | Eagle Labs Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 5% Camphor 3% 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 12 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Aloe Barbadensis Inner Leaf Juice, Aqua, Arnica Montana Flower Extract, Ricinus Communis (Castor) Seed Oil, Cetyl Myristoleate, Glycerin USP, Caprylyl Glycol, Glyceryl Laurate, Glyceryl Undecylenate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Methyl Sulfonyl Methane, Palmitoylethanolamide, Butyrospermum Parkii (Shea) Butter, D-Alpha Tocopheryl Acetate, Curcuma Longa (Turmeric) Root Extract, Salix Alba (Willow) Bark Extract.
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 minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and 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.Healthy Back Institute Rub On Relief Analgesic MENTHOL MENTHOL ALOE VERA LEAF ARNICA MONTANA FLOWER CASTOR OIL CETYL MYRISTOLEATE WATER GLYCERIN CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) GLYCERYL LAURATE GLYCERYL RICINOLEATE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) LAVENDER OIL DEMETON-S-METHYLSULFONE 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-(PHOSPHO-RAC-(1-GLYCEROL)) SHEA BUTTER WILLOW BARK DISODIUM .ALPHA.-TOCOPHERYL PHOSPHATE, D- TURMERIC White to off white - opaque
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.RUB THE PAIN AWAY Rub On Relief Net Wt 3.0 OZ (88mL) HBI Rub On Relief 3OZ Label
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 Keep out of the reach of children. If accidentally swallowed get medical help or contact a Poison Control Center immediately.
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: The condition worsens or symptoms persist for more than 7 days or clear up and reoccur, redness or swelling is present, irritation develops
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 When using this product ▪ use only as directed ▪ do not apply heat (heating pads) or apply patches to area ▪ do not use with other topical analgesics - avoid contact with eyes, mucos membranes, and genital area - Do not expose application site to heat or direct sunlight
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding: If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately
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 ▪Avoid contact with the eyes ▪ Do not apply to wounds or bandaged skin ▪ Do not bandage Stop use and consult a doctor if: ▪ condition worsens ▪ symptoms persist for more than 7 days or clear up and reoccur ▪redness is present ▪irritation develops Keep out of reach of children Keep out of the reach of children. If accidentally swallowed get medical help or contact a Poison Control Center immediately. If pregnant or breast-feeding: If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately Stop Usage immediately and as a doctor if: The condition worsens or symptoms persist for more than 7 days or clear up and reoccur, redness or swelling is present, irritation develops
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