Otc - Active Ingredient
Hydrocortisone 1%
Bloop Itch Soothing Topical Cream
FDA Label NDC 83838-415
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Three Nations Corp for the product Bloop Itch Soothing Topical (NDC 83838-415). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anti-itch
Indications & Usage
- 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
Warnings
For external use only.
Do not use
- in the genital area if you have genital itch associated with penile or vaginal discharge
- 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
- 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.
When using this product
Stop use and ask a doctor if
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
Dosage & Administration
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.
- 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
For external anal and genital itching adults:
Inactive Ingredient
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
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