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Bloop itch soothing topical - Medication Information

Product NDC Code 83838-415
Drug Name

Bloop itch soothing topical

Type Brand
Pharm Class Corticosteroid Hormone Receptor Agonists [MoA],
Corticosteroid [EPC]
Active Ingredients
Hydrocortisone 1 g/100g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 106258
Application Number M017
Labeler Name Three Nations Corp
Packages
Package NDC Code Description
83838-415-01 1 tube in 1 box (83838-415-01) / 28 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Hydrocortisone 1%

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.
For itching or skin irritation, inflammation, and rashes: Adults and children 12 years and older: apply to the affected area 3 to 4 times daily until symptoms resolve or for a maximum of two weeks. For external anal and genital itching adults: gently dry by patting or blotting with toilet tissue or soft cloth before applying product may be applied to the skin of the anal canal with a clean finger apply to affected area not more than 3 to 4 times daily Children under 12 years of age consult a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Aloe barbadensis leaf extract, carapa guianensis seed oil, cetearyl alcohol, cetyl alcohol, chamomilla recutita (matricaria) flower extract, dimethicone, disodium EDTA, ethylhexylglycerin, glycerin, methyl gluceth-20, orbignya oleifera seed oil, petrolatum, phenoxyethanol, polysorbate 60, potassium hydroxide, propanediol, steareth-2, steareth-21, stearyl alcohol, tocopheryl acetate, 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.
Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema insect bites seborrheic dermatitiss psoriasis Temporarily relieves external genital, feminine, and anal itching Other uses of this product should only be under the advice and supervision of a doctor

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
Bloop Itch Soothing Topical Hydrocortisone POLYSORBATE 60 STEARETH-21 BABASSU OIL POTASSIUM HYDROXIDE HYDROCORTISONE HYDROCORTISONE PETROLATUM ALOE VERA LEAF CARAPA GUIANENSIS SEED OIL CETOSTEARYL ALCOHOL CETYL ALCOHOL EDETATE DISODIUM CHAMOMILE PROPANEDIOL DIMETHICONE 200 ETHYLHEXYLGLYCERIN GLYCERIN .ALPHA.-TOCOPHEROL ACETATE WATER METHYL GLUCETH-20 PHENOXYETHANOL STEARETH-2 STEARYL 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.
Carton

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.
If swallowed, get medical help or contact a Poison Control Center immediately.

Pregnancy or breast feeding

Pregnancy or Breast feeding
Ask a health professional before use.

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.
For external use only. Do not use in the genital area if you have genital itch associated with penile or vaginal discharge When using this product avoid contact with eyes do not exceed recommended dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsens condition does not improve within 7 days or bleeding persists beyond 7 days and do not begin use of any other hydrocortisone product.

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