BLOOP ITCH SOOTHING TOPICAL- hydrocortisone cream 
Three Nations Corp

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Bloop Itch Soothing Topical Cream

Hydrocortisone 1%

Anti-itch

For external use only.

Do not use

When using this product

Stop use and ask a doctor if

Ask a health professional before use.

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

For itching or skin irritation, inflammation, and rashes:

For external anal and genital itching adults:

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

Carton

BLOOP ITCH SOOTHING TOPICAL 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83838-415
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83838-415-011 in 1 BOX11/14/2023
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/14/2023
Labeler - Three Nations Corp (119050054)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(83838-415)

Revised: 11/2023
Document Id: 0b64677e-d4be-0929-e063-6294a90af137
Set id: 0b64677e-d4bf-0929-e063-6294a90af137
Version: 1
Effective Time: 20231130
 
Three Nations Corp