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Family care maximum strength medicated anti itch - Medication Information

Product NDC Code 65923-104
Drug Name

Family care maximum strength medicated anti itch

Type Brand
Active Ingredients
Menthol 10 mg/g
Pramoxine hydrochloride 10 mg/g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 1116155
Application Number part346
Labeler Name United Exchange Corp.
Packages
Package NDC Code Description
65923-104-14 1 tube in 1 carton (65923-104-14) / 14 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Purpose Menthol 1%.........................................................................Anti-itch/Topical analgesic Pramoxine HCl 1%..............................................................Anti-itch/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.
Distributed By: UNITED EXCHANGE CORPORATION Cypress, CA 90630 USA | 1-888-645-8204 Made in China

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients aloe vera leaf, carbomer 940, glycerin, glyceryl monostearate, isopropyl myristate, methyl salicylate, methylparaben, mineral oil, polysorbate 60, propylparaben, purified water, sodium hydroxide, stearyl alcohol, tocopheryl acetate

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.
Directions not for prolonged use 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.

Purpose

Information about the drug product’s indications for use.
Uses for temporary relief of pain and itching associated with: minor skin irritations minor cuts minor burns minor sunburns scrapes insect bites rashes due to poison ivy, oak, or sumac

Spl product data elements

Usually a list of ingredients in a drug product.
Family Care Maximum Strength Medicated Anti Itch Menthol ALOE VERA LEAF CARBOMER HOMOPOLYMER TYPE C GLYCERIN GLYCERYL MONOSTEARATE ISOPROPYL MYRISTATE METHYLPARABEN METHYL SALICYLATE MINERAL OIL POLYSORBATE 60 PROPYLPARABEN STEARYL ALCOHOL WATER MENTHOL MENTHOL PRAMOXINE HYDROCHLORIDE PRAMOXINE SODIUM HYDROXIDE ALPHA-TOCOPHEROL ACETATE

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.
10497.1

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 deep or puncture wounds animals bites serious burns large areas of the body

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 (1-800-222-1222) 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 1-888-645-8204 Monday-Friday 9AM-5PM (PST)

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 persist for more than 7 days or clear up and occur again within a few days if redness, irritation, swelling or pain persists or increases

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 nose.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at room temperature 20-25°C (68-77°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.

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