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| Product NDC Code | 35192-053 | ||||
|---|---|---|---|---|---|
| Drug Name | Dr bump gel 16 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| Application Number | M017 | ||||
| Labeler Name | CA-BOTANA INTERNATIONAL | ||||
| 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.OTC - ACTIVE INGREDIENT Menthol 5% 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.Dosage & Admnistration External topical analgesic Topical massage gel no more than 4 times daily
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Aesculus hippocastanum (Horse Chestnut), Aloe barbadensis miller, Aloe barbadensis miller (Aloe Vera), Amonium Acrylcydimethyltaurate/VPCcopolymer, Arnica montana (Arnica), Bromelain, Butylene Glycol, Capsicum annum ( Capsicum), Chamaemelum nobile (Chamomile), Ethyl alcohol, Eucalyptus globules (Eucaliptus) oil, FD&C Green # 3, Glucosamine Sulfate, Harpagophytum procumbens (Devil’s Claw), Melissa officinalis (Lemon Balm), Methyl Sulfonyl Methane (MSM), Polysorbate-60, Potassium Sorbate, Purified Water, Rosmarinus officinalis (Rosemary), Salix alba (Willow Bark), Edetic Acid, Tilia cordata (Linden), Xanthan Gum
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.Indications & usage Apply generous amount of gel directly affected area massage into painful area until thoroughly absorbed into skin
Purpose
Information about the drug product’s indications for use.OTC - PURPOSE SECTION Uses: for temporary relief of minor aches and pains of muscles and joints associated with. simple aches. back aches. arthritis.strains.bruises.sprains.
Spl product data elements
Usually a list of ingredients in a drug product.Dr Bump gel 16 Menthol CHAMAEMELUM NOBILE FLOWER EUCALYPTUS OIL MENTHOL MENTHOL ARNICA MONTANA POTASSIUM SORBATE SALIX ALBA BARK HORSE CHESTNUT BROMELAINS BUTYLENE GLYCOL CAPSICUM TILIA CORDATA FLOWER GLUCOSAMINE SULFATE MELISSA OFFICINALIS DIMETHYL SULFONE AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER HARPAGOPHYTUM PROCUMBENS ROOT POLYSORBATE 60 WATER ROSEMARY EDETIC ACID ALCOHOL XANTHAN GUM ALOE VERA LEAF
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.Label Dr Bump 16 Oz.jpg
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.OTC - ASK DOCTOR Stop use and ask a doctor if redness is present.irritation develops. conditions worsens or symtoms persist more than 7 days. symtoms clear up and occur again within a few days
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 reach of children
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Safety Information Protect this product from excessive heat and direct sun
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 Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away
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