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Anti-itch soothing wipes 1 pramoxine hydrochloride - Medication Information

Product NDC Code 82637-9363
Drug Name

Anti-itch soothing wipes 1 pramoxine hydrochloride

Type Brand
Active Ingredients
Pramoxine hydrochloride 10 mg/ml
Route TOPICAL
Dosage Form CLOTH
RxCUI drug identifier 1039541
Application Number M017
Labeler Name The Honey Pot Company LLC
Packages
Package NDC Code Description
82637-9363-1 30 patch in 1 pouch (82637-9363-1) / 2.8 ml in 1 patch
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient: Pramoxine Hydrochloride 1% Purpose: External 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: Adults and children 12 years of age and older: Children under 12 years of age: Consult a doctor Apply to affected area not more than 3 or 4 times daily.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients: Aloe Barbadensis Leaf Extract, *Aloe Barbadensis Leaf Juice, Althaea officinalis Root Extract, Avena Sativa (Oat) Kernel Extract, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocos Nucifera (Coconut) Fruit Extract, Cucumis Sativus (Cucumber) Fruit Extract, Disodium Cocoamphodiacetate, Ethylhexylglycerin, Euterpe Oleracea Fruit Extract, Fragrance, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Helianthus Annuus (Sunflower) Seed Oil, *Honey, Lactobacillus, Lactobacillus Ferment, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polyglyceryl-4 Caprate, Punica Granatum Fruit Extract, Rosa Centifolia Flower Water, Sodium Chloride, Tetrasodium Glutamate Diacetate Tocopheryl Acetate, *Vinegar (Apple Cider), Water *Organic Ingredients

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 skin irritations

Purpose

Information about the drug product’s indications for use.
Purpose: External Analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
Anti-Itch Soothing Wipes 1 Pramoxine Hydrochloride PRAMOXINE HYDROCHLORIDE ALOE VERA LEAF ALTHAEA OFFICINALIS ROOT OAT CALENDULA OFFICINALIS FLOWER CHAMOMILE CITRIC ACID MONOHYDRATE COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE COCONUT CUCUMBER DISODIUM COCOAMPHODIACETATE ETHYLHEXYLGLYCERIN ACAI GLYCERIN HAMAMELIS VIRGINIANA TOP WATER SUNFLOWER OIL HONEY LAVENDER OIL PHENOXYETHANOL POLYGLYCERYL-4 CAPRATE POMEGRANATE ROSA CENTIFOLIA FLOWER OIL SODIUM CHLORIDE TETRASODIUM GLUTAMATE DIACETATE .ALPHA.-TOCOPHEROL ACETATE ACETIC ACID WATER PRAMOXINE HYDROCHLORIDE PRAMOXINE

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: Outer Package

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 a controlled room temperature 77°F (20-25°C).

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 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: For questions and general information visit us at www.thehoneypot.co/contact

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 doctor if: Condition worsens If symptoms persist for more than 7 days, or clear up and reoccur again withing 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.

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 doctor if: Condition worsens If symptoms persist for more than 7 days, or clear up and reoccur again withing a few days Keep out of reach of 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