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Product NDC Code | 24286-1554 | ||||||
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Drug Name | Earths care pain relieving |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | OINTMENT | ||||||
RxCUI drug identifier | 1232299 | ||||||
Application Number | M017 | ||||||
Labeler Name | DLC Laboratories, Inc. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Camphor 4% Menthol 10% Methyl Salicylate (Wintergreen Oil) 15% 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 use only as directed adults and children 12 years of age and older: apply to affected area not more than 3 or 4 times daily. avoid overuse on large areas of the skin wash hands thoroughly after application children under 12 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients beeswax, Butyrospermum parkii (shea) butter, Prunus amygdalus dulcis (sweet almond) oil, Rosmarinus officinialis (rosemary) extract, tocopherol (natural vitamin E)
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 Temporarily relieves the minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises 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.Earths Care Pain Relieving CAMPHOR, MENTHOL, METHYL SALICYLATE YELLOW WAX ROSEMARY SHEA BUTTER ALMOND OIL TOCOPHEROL CAMPHOR (NATURAL) CAMPHOR (NATURAL) MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM METHYL SALICYLATE SALICYLIC ACID
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.PRINCIPAL DISPLAY PANEL - 71 g Jar Box EARTH'S CARE ™ Allergy Tested PARABEN FREE TRIPLE ACTION Pain Relieving Ointment Relieves Minor Backache, Sprains, Muscle & Joint Pain 1% FOR THE PLANET ℠ MEMBER 2.5 OZ. (71 g) Principal Display Panel - 71 g Jar Box
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.Origins Natural Camphor is found in the wood of the Camphor Laurel tree (Cinnamomum camphora), an evergreen species from Asia. Natural Menthol is a substance found in peppermint and in other mint oils. Natural Wintergreen Oil is extracted from the leaves of wintergreen plants such as the Eastern Teaberry (Gaultheria procumbens). Indications Earth's Care Pain Relieving Ointment is a powerful blend of three natural ingredients that provide soothing, penetrating relief from sore muscles, joint pain, backache and minor arthritis. Our proprietary formula features naturally-sourced Camphor, Menthol and Wintergreen Oil that together work as an effective analgesic without parabens or phthalates. No Preservatives No Animal Testing No Artificial Colors or Fragrances No Petrolatum Triple Action Formula: Camphor Menthol Wintergreen Oil RETAIN CARTON FOR COMPLETE DRUG FACTS. Distributed by: Earth's Care Natural Products, Inc. Long Beach, California 90805 USA Questions: 1-888-602-6380 earths-care.com
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.Ask a doctor before use if here is redness over the affected area.
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 with a heating pad or other heat sources (may blister skin) on children under 12 years of age on wounds or damaged skin if you are taking anticoagulant medication
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? call 1-888-602-6380
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 and ask a doctor if skin redness or excessive irritation of the skin develops symptoms clear up and occur again within a few days condition worsens or if symptoms persist for more than 7 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 the eyes and 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. Allergy Alert: If you are allergic to aspirin or salicylates, consult a doctor before use. Do not use with a heating pad or other heat sources (may blister skin) on children under 12 years of age on wounds or damaged skin if you are taking anticoagulant medication Ask a doctor before use if here is redness over the affected area. When using this product avoid contact with the eyes and mucous membranes do not bandage tightly Stop and ask a doctor if skin redness or excessive irritation of the skin develops symptoms clear up and occur again within a few days condition worsens or if symptoms persist for more than 7 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.
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