BLOOP FISSURE HEALING ANORECTAL TOPICAL- lidocaine cream 
Three Nations Corp

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Bloop Fissure Healing Topical Anorectal Cream

Lidocaine 5%

Anorectal (hemorrhoidal)

For external use only (skin of the perianal area and anal canal).

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.

Benzyl alcohol, carbomer, cholesterol, euterpe oleracea fruit oil, hydrogenated lecithin, isopropyl myristate, pentaclethra macroloba seed oil, polysorbate 80, propanediol, tocopheryl acetate, triethanolamine, water.

Carton

BLOOP FISSURE HEALING ANORECTAL TOPICAL 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83838-153
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
ACAI OIL (UNII: Z0W6766A2W)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
PROPANEDIOL (UNII: 5965N8W85T)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PENTACLETHRA MACROLOBA SEED OIL (UNII: OM0BAV5397)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83838-153-011 in 1 CARTON11/14/2023
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 DrugM01511/14/2023
Labeler - Three Nations Corp (119050054)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(83838-153)

Revised: 11/2023
Document Id: 0b645092-ebc3-e4bb-e063-6294a90ad4cf
Set id: 0b645092-ebc4-e4bb-e063-6294a90ad4cf
Version: 1
Effective Time: 20231130
 
Three Nations Corp