HEMORRHOID ANESTHETIC- mineral oil, petrolatum, phenylephrine hcl ointment 
Universal Distribution Center LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Hemorrhoid Anesthetic Ointment

Active Ingredients

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCL 0.25%

Purpose

Protectant

Protectant

Vasoconstrictor

Uses

Warnings

For external use only

Keep out of reach of children.

If ingested seek medical attention immediately or contact a Poison Control Center right away.

Directions

Other Information

Inactive Ingredients

Purified water, benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, mineral oil, paraffin, propylparaben, shark liver oil, thyme oil, tocopherol acetate, yellow wax.

PRINCIPAL DISPLAY PANEL

Hemorrhoid Anesthetic Ointment

NET WT 1 OZ (28 g)

image of package label

HEMORRHOID ANESTHETIC 
mineral oil, petrolatum, phenylephrine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-028
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM0.749 g  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.0025 g  in 1 g
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL0.14 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
CORN OIL (UNII: 8470G57WFM)  
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SHARK LIVER OIL (UNII: 4B24275HEU)  
THYME OIL (UNII: 2UK410MY6B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52000-028-371 in 1 CARTON08/05/2016
1NDC:52000-028-3928 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34608/05/2016
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-028)

Revised: 2/2022
Document Id: d8870c0f-85ea-e5d9-e053-2a95a90a4489
Set id: 3955ed28-e2b5-1695-e054-00144ff8d46c
Version: 3
Effective Time: 20220221
 
Universal Distribution Center LLC