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| Product NDC Code | 14448-445 | ||||
|---|---|---|---|---|---|
| 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 | ||||
| Packages |
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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 or 4 times a day.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Anthemis Nobilis (Roman Chamomile) Oil, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Arnica Montana Flower Extract, Ascorbyl Palmitate (Vitamin C), Calendula Officinalis Extract, Caprylyl Glycol, Centaurea Cyanus (Cornflower) Extract, Chamomilla Recutita (Chamomile) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Glycerin, Hamamelis Virginiana (Witch Hazel), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Phenoxyethanol, Salix Nigra (Willow) Bark Extract, Sodium Cocoyl Isethionate, Sodium Hydroxide, Sorbitol, Tanacetum Parthenium (Feverfew) Extract, 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: Temporary relief minor aches, pains associated with arthritis, simple backache, 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 ALOE VERA LEAF WATER ARGAN OIL ARNICA MONTANA FLOWER ASCORBYL PALMITATE CALENDULA OFFICINALIS FLOWER CAPRYLYL GLYCOL CHAMOMILE CORIANDER EMU OIL GLYCERIN WITCH HAZEL DIMETHYL SULFONE PHENOXYETHANOL SALIX NIGRA BARK SODIUM COCOYL ISETHIONATE SODIUM HYDROXIDE SORBITOL FEVERFEW EDETATE SODIUM TILIA CORDATA WHOLE .ALPHA.-TOCOPHEROL ACETATE VITIS VINIFERA SEED 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: Label
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 Posion Control Center right away.
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 clear up and occur again within 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. Consult a doctor before use on children under 12 if arthritis conditions are present. For all other listed uses, consult a doctor before use on children under 2.
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 clear up and occur again within few days. If Pregnant or Breast-Feeding ask a health professional before use. Consult a doctor before use on children under 12 if arthritis conditions are present. For all other listed uses, consult a doctor before use on children under 2. Keep out of reach of children. If swallowed, get medical help or contact a Posion 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