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Insect sting relief - Medication Information

Product NDC Code 50814-041
Drug Name

Insect sting relief

Type Brand
Pharm Class Allergens [CS],
Cell-mediated Immunity [PE],
Increased Histamine Release [PE],
Standardized Chemical Allergen [EPC]
Active Ingredients
Alcohol 600 mg/ml
Benzocaine 60 mg/ml
Route TOPICAL
Dosage Form SWAB
RxCUI drug identifier 1046313
Application Number M017
Labeler Name GFA Production (Xiamen) Co., Ltd.
Packages
Package NDC Code Description
50814-041-01 .18 ml in 1 pouch (50814-041-01)
50814-041-02 .53 ml in 1 pouch (50814-041-02)
50814-041-03 .225 ml in 1 pouch (50814-041-03)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient: Benzocaine, 6% w/v SD alcohol, 60% w/v Purpose: Topical Anesthetic Anesthetic

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients: Purified water.

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.
Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

Purpose

Information about the drug product’s indications for use.
Purpose: Topical Anesthetic Anesthetic

Spl product data elements

Usually a list of ingredients in a drug product.
INSECT STING RELIEF BENZOCAINE, ALCOHOL WATER BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL

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: Label

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 - Insect Sting Relief Pad

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: In eyes, on broken skin, deep puncture wounds. If unsual redness, swelling, irritation or other symptoms occur, consult a physician immediately.

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 Contrl Center right away. Flammable - keep away from fire or flame. Avoid contact with eyes. If this happens, rinse thoroughly with water

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. Do not use: In eyes, on broken skin, deep puncture wounds. If unsual redness, swelling, irritation or other symptoms occur, consult a physician immediately. Keep out of reach of children. If swallowed, get medical help or contact a Poison Contrl Center right away. Flammable - keep away from fire or flame. Avoid contact with eyes. If this happens, rinse thoroughly with water

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