HEMORRHOID ANESTHETIC- mineral oil, petrolatum, phenylephrine hcl ointment 
Anicare Pharmaceuticals Pvt. Ltd

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.

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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

benzoic acid, butylated hydroxyanisole, glycerin, lanolin, lanolin alcohol, methylparaben, paraffin, propylparaben, 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:47046-153
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL0.14 g  in 1 g
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
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47046-153-021 in 1 CARTON12/09/2020
1NDC:47046-153-0128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34612/09/2020
Labeler - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Revised: 12/2020
Document Id: b6ae8bbc-b8ef-6293-e053-2995a90a795c
Set id: b6ae8c5a-2206-781f-e053-2995a90a3175
Version: 1
Effective Time: 20201213
 
Anicare Pharmaceuticals Pvt. Ltd