Label: BLOOP ITCH SOOTHING TOPICAL- hydrocortisone cream
- NDC Code(s): 83838-415-01
- Packager: Three Nations Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 30, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
-
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
- KEEP OUT OF REACH OF CHILDREN
-
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 creamProduct 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)