BLOOP ITCH SOOTHING TOPICAL- hydrocortisone cream

Bloop Itch Soothing Topical by

Drug Labeling and Warnings

Bloop Itch Soothing Topical by is a Otc medication manufactured, distributed, or labeled by Three Nations Corp, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Hydrocortisone 1%

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

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.

PREGNANCY OR BREAST FEEDING

Ask a health professional before use.

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.

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BLOOP ITCH SOOTHING TOPICAL 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83838-415
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARETH-21 (UNII: 53J3F32P58)
BABASSU OIL (UNII: 8QSB4M5477)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PETROLATUM (UNII: 4T6H12BN9U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARAPA GUIANENSIS SEED OIL (UNII: Y82418EH2I)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CHAMOMILE (UNII: FGL3685T2X)
PROPANEDIOL (UNII: 5965N8W85T)
DIMETHICONE 200 (UNII: RGS4T2AS00)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARETH-2 (UNII: V56DFE46J5)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83838-415-01	1 in 1 BOX	11/14/2023
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/14/2023

Labeler - Three Nations Corp (119050054)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(83838-415)