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Product NDC Code | 70631-034 | ||||
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Drug Name | Lavaderm after sun for pain and itching |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SPRAY | ||||
RxCUI drug identifier | 1314935 | ||||
Application Number | M017 | ||||
Labeler Name | Young Living Essential Oils, LC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 0.5%
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 Shake Well Adults and children 2 years of age and older : apply to affected area not more than 3 to 4 times daily. Children under 2 years of age : ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, olive oil, glycerin, safflower oil, sunflower oil, jojoba oil, polyglyceryl-10 pentastearate, glyceryl monocaprylate, helianthus annuus seed wax, European elderberry, xanthan gum, docosanol, sodium stearoyl lactylate, lavender oil, aloe vera leaf, glyceryl monoundecylenate, phytate sodium, picea mariana leaf oil, helichrysum italicum flower oil, citric add
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 pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations
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.Lavaderm After Sun For Pain and Itching Menthol DOCOSANOL XANTHAN GUM PICEA MARIANA LEAF OIL GLYCERYL MONOCAPRYLATE WATER OLIVE OIL GLYCERIN HELIANTHUS ANNUUS SEED WAX SAFFLOWER OIL SUNFLOWER OIL JOJOBA OIL POLYGLYCERYL-10 PENTASTEARATE EUROPEAN ELDERBERRY SODIUM STEAROYL LACTYLATE LAVENDER OIL ALOE VERA LEAF GLYCERYL MONOUNDECYLENATE ANHYDROUS CITRIC ACID HELICHRYSUM ITALICUM FLOWER OIL PHYTATE SODIUM MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM
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 FOR PAIN & ITCH SOOTHES & COOLS SKIN IMMEDIATE RELIEF Box Label
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 to avoid accidental ingestion . 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 1-800-371-3515
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 condition worsens symptoms last more than 7 days or clear 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
Storage and handling
Information about safe storage and handling of the drug product.Other information store at controlled room temperature (68° to 77°F)
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 When using this product avoid contact with eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. Keep out of reach of children to avoid accidental ingestion . 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