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Product NDC Code | 72663-636 | ||||
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Drug Name | Bump and bruise reliever |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 1045482 | ||||
Application Number | part348 | ||||
Labeler Name | Welly Health PBC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 1.5%
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 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily, massage not necessary • Children under 2 years of age: Consult physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Acrylamide Sodium Acryloyldimethyl Taurate Copolymer, Aqua, Arnica, Castor Oil, Cetostearyl Alcohol, Glycerin, Isohexadecane, Polysorbate 80, Sodium Benzoate, Sorbitan Monooleate, Sorbitol
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 from minor aches and pains of muscles & joints associated with: • backache • strains • bruises • sprains
Purpose
Information about the drug product’s indications for use.Purpose Pain Relief
Spl product data elements
Usually a list of ingredients in a drug product.Bump and Bruise Reliever MENTHOL MENTHOL, UNSPECIFIED FORM MENTHOL SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) WATER ARNICA MONTANA FLOWER CASTOR OIL CETOSTEARYL ALCOHOL GLYCERIN ISOHEXADECANE POLYSORBATE 80 SODIUM BENZOATE SORBITAN MONOOLEATE SORBITOL
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.Packaging IMAGE
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
Menthol Pain Relief Cream FREE FROM x Alcohol Parabens Sulfates Mineral Oil Fragrance FRAGRANCE FREE KID FRIENDLY MADE WITH SQUEAKY CLEAN INGREDIENTS FOR HAPPY HEALING SQUEAKY CLEAN FIRST AID Formulated with naturally derived plant-based ingredients ARNICA known to help minimize the appearance of bruises CASTOR OIL known to help soothe skin HELPS PROVIDE TEMPORARY PAIN RELIEF FROM aches sore muscles sprains bruises Packaging is recyclable. Distributed by Welly Health PBC Minneapolis, MN 55402 1-833-BE-WELLY | getwelly.com Product of USA and Canada with globally sourced materials.
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 the reach of children: If accidentally ingested, 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 Store in a cool dry place with lid closed tightly
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. Flammable: Keep away from excessive heat or open flame. Ask a doctor before use if you have: sensitive skin When using this product • Avoid contact with the eyes or mucous membranes • Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays or liniments • Do not apply to irritated skin or if excessive irritation develops • Do not bandage • Wash hands after use with cool water • Do not use with heating pad or device Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur If pregnant or breastfeeding: Ask a health professional before use Keep out of the reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.
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