Bloop Itch Soothing Topical Cream

Bloop Itch Soothing Topical Cream
SPL v1
SPL
SPL Set ID 0b64677e-d4bf-0929-e063-6294a90af137
Route
TOPICAL
Published
Effective Date 2023-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Polysorbate 60 Steareth-21 Babassu Oil Potassium Hydroxide 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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-14

Description

Hydrocortisone 1%


Medication Information

Warnings and Precautions

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.
Indications and 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
Dosage and 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.

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
Description

Hydrocortisone 1%

Section 50565-1

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

Section 51727-6

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

Section 51945-4

Section 53414-9

Ask a health professional before use.

Section 55105-1

Anti-itch

Section 55106-9

Hydrocortisone 1%


Structured Label Content

Indications and Usage (34067-9)
  • 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
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

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.
Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Anti-itch

Section 55106-9 (55106-9)

Hydrocortisone 1%


Advanced Ingredient Data


Raw Label Data

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