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| Product NDC Code | 14448-307 | ||||
|---|---|---|---|---|---|
| Drug Name | Super white stuff pain relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 2391332 | ||||
| Application Number | M017 | ||||
| Labeler Name | BLUE SPRING WELLNESS, L.L.C. | ||||
| 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, USP 1.4% 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 Apply to affected area not more than 3 to 4 times a days. before using for children under 12 for arthritic conditions and for all children under 2 years of age for all other uses. Consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingrediets Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Anthemis Nobilis (Roman Chamomile) Oil, Aqua (Deionized Water), Arnica Montana Flower Extract, Ascorbyl Palmitate (Vitamin C), Calendula Officinalis Extract, Caprylyl Glycol, Centraurea Cyanus (Cornflower) Extract, Chamomilla Recutita (Chamomile) Extract, Chrysanthemum Parthenium (Feverfew) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Hamamelis Virginiana (Witch Hazel), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Phenoxyethanol, Salix Nigra (Willow) Bark Extract, Sodium Cocoyl Isethionate, Sodium Hydroxide, Sorbitol, Tetrasodium EDTA, Tilia Cordata (Linden) Extract, Tocopheryl Acetate (Vitamin E), Vitis Vinifera (Grape) Seed 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 the temporary relief of minor aches and pains associated with arthritis simple backahe sprains strains bruises
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.SUPER WHITE Stuff Pain Relief MENTHOL WATER ARNICA MONTANA FLOWER ASCORBYL PALMITATE CALENDULA OFFICINALIS FLOWER CAPRYLYL GLYCOL CHAMOMILE TANACETUM PARTHENIUM WHOLE CORIANDER EMU OIL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK LAMIUM ALBUM WHOLE DIMETHYL SULFONE PHENOXYETHANOL SALIX NIGRA BARK SODIUM COCOYL ISETHIONATE SODIUM HYDROXIDE SORBITOL EDETATE SODIUM TILIA CORDATA WHOLE .ALPHA.-TOCOPHEROL ACETATE VITIS VINIFERA SEED CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) ALOE VERA LEAF MENTHOL MENTHOL
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.Package Labeling:355 Label3
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information Store at room temperature.
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.Consult a doctor before use on children under 12 years of age if arthritis conditions are present. For all other listed uses, consult a doctor before use on children under 2 years of age.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on wounded, damaged or irritated skin.
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 swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? Call or visit www.bluestuff.com 1-800-452-3700
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 use and ask a doctor if you experience a rash and/or a reaction condition worsens or if symptoms persist for more than 10 days or clears up and occur again within a few 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 avoid contact with eyes or mucous membranes. Do not bandage tightly
Pregnancy or breast feeding
Pregnancy or Breast feedingIf Pregnant or Breast-Feeding ask a health professional before use.
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 on wounded, damaged or irritated skin. When using this product avoid contact with eyes or mucous membranes. Do not bandage tightly Stop use and ask a doctor if you experience a rash and/or a reaction condition worsens or if symptoms persist for more than 10 days or clears up and occur again within a few days. If Pregnant or Breast-Feeding ask a health professional before use. Consult a doctor before use on children under 12 years of age if arthritis conditions are present. For all other listed uses, consult a doctor before use on children under 2 years of age. Keep out of reach of children. If 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