HEMORRHOID ANESTHETIC- mineral oil, petrolatum, phenylephrine hcl ointment

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP), PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
Universal Distribution Center LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Protectant Protectant Vasoconstrictor Uses - For the temporary relief of local anorectal burning and discomfort associated with hemmorrhoids, anorectal disorders, inflamed hemorrhoidal tissues or piles. - Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clean-up and occur again within a few days. - Do not exceed the recommended daily dosage unless directed by a doctor. - In case of bleeding, consult a doctor promptly. - Certain persons can develop allergic reactions to ingredients in this product. - If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor. - If you are pregnant, do not use this product without first consulting a doctor.
Authorization status:
OTC monograph final
Authorization number:
52000-057-01

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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.

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Hemorrhoid Anesthetic Ointment

Active Ingredients

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCL 0.25%

Purpose

Protectant

Protectant

Vasoconstrictor

Uses

For the temporary relief of local anorectal burning and discomfort associated with hemmorrhoids,

anorectal disorders, inflamed hemorrhoidal tissues or piles.

Warnings

For external use only.

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or

clean-up and occur again within a few days.

Do not exceed the recommended daily dosage unless directed by a doctor.

In case of bleeding, consult a doctor promptly.

Certain persons can develop allergic reactions to ingredients in this product.

If the symptom being treated does not subside or if redness, irritation, swelling, pain or other

symptoms develop or increase, discontinue use and consult a doctor.

If you are pregnant, do not use this product without first consulting a doctor.

Keep out of reach of children.

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

Directions

Cleanse the affected area with mild soap and warm water, rinse thoroughly.

Dry by patting or blotting with toilet tissue or soft cloth before applying this product.

Cover the entire affected area with a thin layer 1 to 3 times daily.

Children under 12 years of age need to consult a doctor before using this product.

Other Information

Store at 20ºC to 25ºC (68ºF to 77ºF)

Lot No. & Exp. Date: see crimp of tube.

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)

HEMORRHOID ANESTHETIC

mineral oil, petrolatum, phenylephrine hcl ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:520 0 0 -0 57

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MINERAL O IL (UNII: T5L8 T28 FGP) (MINERAL OIL - UNII:T5L8 T28 FGP)

MINERAL OIL

0 .14 g in 1 g

PETRO LATUM (UNII: 4T6 H12BN9 U) (PETROLATUM - UNII:4T6 H12BN9 U)

PETROLATUM

0 .749 g

in 1 g

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

0 .0 0 25 g

in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

Universal Distribution Center LLC

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

BUTYLATED HYDRO XYANISO LE (UNII: REK49 6 0 K2U)

GLYCERIN (UNII: PDC6 A3C0 OX)

LANO LIN (UNII: 7EV6 5EAW6 H)

LANO LIN ALCO HO LS (UNII: 8 8 4C3FA9 HE)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PARAFFIN (UNII: I9 O0 E3H2ZE)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

YELLO W WAX (UNII: 2ZA36 H0 S2V)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:520 0 0 -0 57-0 1

1 in 1 CARTON

12/0 9 /20 20

1

28 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt346

12/0 9 /20 20

Labeler -

Universal Distribution Center LLC (019180459)

Registrant -

Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Anicare Pharmaceuticals Pvt. Ltd

9 16 8 37425

ma nufa c ture (520 0 0 -0 57)

Revised: 12/2020

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