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Rugby anti-itch - Medication Information

Product NDC Code 0536-1268
Drug Name

Rugby anti-itch

Type Brand
Active Ingredients
Camphor (synthetic) .5 g/100g
Menthol .5 g/100g
Route TOPICAL
Dosage Form LOTION
RxCUI drug identifier 200176
Application Number part348
Labeler Name RUGBY LABORATORIES
Packages
Package NDC Code Description
0536-1268-12 212 g in 1 bottle, pump (0536-1268-12)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Camphor 0.5%............................................................................................................................ External analgesic Menthol 0.5%.............................................................................................................................. 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 to open, squeeze cap tightly and turn pump counter-clockwise adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily children under 2 years: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients carbomer 940, cetyl alcohol, DMDM hydantoin, fragrance, glyceryl stearate, isopropyl myristate, PEG-40 stearate, PEG-100 stearate, purified water, sodium hydroxide, stearic acid, white petrolatum

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 relieves pain and itching due to: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak, and poison sumac dries the oozing and weeping of poison: ivy oak sumac

Purpose

Information about the drug product’s indications for use.
Purpose Anti - itch

Spl product data elements

Usually a list of ingredients in a drug product.
Rugby Anti-Itch Camphor, Menthol ISOPROPYL MYRISTATE WATER PEG-40 STEARATE CETYL ALCOHOL PEG-100 STEARATE STEARIC ACID DMDM HYDANTOIN SODIUM HYDROXIDE CARBOMER 940 PETROLATUM CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) MENTHOL 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 rugby .jpg

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.

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 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 do not get into eyes

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 20 °C to 25 °C (68 °F 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.
Warning For external use only when using this product do not get into eyes Stop Use and ask 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 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