Anesthetic Hemorrhoidal

Manufacturer
Personal Care Products, Inc. | Anicare Pharmaceuticals Pvt. Ltd.
Effective date
2020-07-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:22:31

Label at a glance#

ProductAnesthetic Hemorrhoidal With Aloe
Active ingredientPRAMOXINE HYDROCHLORIDE, ZINC OXIDE
Label structure9 sections

Indications and uses

temporarily shrinks hemorrhoidal tissue temporarily relieves itching, burning and discomfort associated with hemorrhoids

Dosage and administration

Direction for adults when practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this ointment, apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement Children under 12 years or age, ask a doctor.

Label contents#

Full prescribing information#

Drug Facts Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCL 1%

Zinc oxide 12.5%

Purpose

OTC - PURPOSE SECTION

Local anesthetic
Protectant

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

temporarily shrinks hemorrhoidal tissue
temporarily relieves itching, burning and discomfort associated with hemorrhoids

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if you have - heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use, if you are presently taking a prescription drug for high blood pressure or depression

When using this product - do not exceed the recommended daily dosage unless directed by a doctor, do not use this product with an applicator, if the applicator into the rectum causes additional pain. Consult a doctor promptly.

Stop use and ask a doctor if - you experience bleeding, condition worsens or does not improve within 7 days, these may be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Direction for adults

when practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this ointment, apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement

Children under 12 years or age, ask a doctor.

Other information

OTHER SAFETY INFORMATION

store between 59° and 86° F (15° and 30° C), close cap tightly after use, do not use if seal on tube is punctured  or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

balsam peru, benzyl benzoate, calcium phohsphate, cocoa butter, glyceryl monostearate, glyceryl monoleate, kaolin, mineral oil, Aloe vera extract

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUGSTORE - Rx

SMART WELLNESS

Anesthetic Hemorrhoidal Ointment With Aloe

Quick and soothing, pain relief from burning, itching and discomfort

Shrinks swollen hemorrhoidal tissue

NET WT. 1.5 OZ. (42 g)

DRUGSTORE-Rx

SMART WELLNESS delivers outstanding quality in healthcare products, at truly amazing prices. We employ the highest standard when searching the world to bring the best value to your doorstep. Use our products confidently, knowing that attention and care has gone into every item  That's smart wellness!

Distributed by: PERSONAL CARE PRODUCTS, LLC

Troy, Michigan 484084  U.S.A.       Code No.MH/DRUGS/KD-313    Made in India


PC Hemorrhodial1 LabelPC Hemorrhodial1 Label

PC Hemorrhodial4 LabelPC Hemorrhodial4 Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1294330pramoxine HCl 1 % / zinc oxide 12.5 % Topical OintmentPSN2
1294330pramoxine hydrochloride 0.01 MG/MG / zinc oxide 0.125 MG/MG Topical OintmentSCD2
1294330Pramoxine hydrochloride 0.01 MG/MG / ZNO 0.125 MG/MG Topical OintmentSY2
1294330pramoxine hydrochloride 1 % / zinc oxide 12.5 % Topical OintmentSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29500-2438-1Anesthetic HemorrhoidalWith Aloe42 g in 1 TUBEOINTMENT422

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29500-2438ANESTHETIC HEMORRHOIDAL WITH ALOE (PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) OINTMENT [PERSONAL CARE PRODUCTS, INC.]2Legacy NDC, 1 package rows20200725_a0e3b500-1295-47cd-ab4e-503f51895bbb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L51
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
PRAMOXINEACTIVE MOIETY068X84E0561
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
BALSAM PERUINACTIVE INGREDIENT8P5F881OCY1
BENZYL BENZOATEINACTIVE INGREDIENTN863NB338G1
CALCIUM PHOSPHATEINACTIVE INGREDIENT97Z1WI3NDX1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRR1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
GLYCERYL OLEATEINACTIVE INGREDIENT4PC054V79P1
KAOLININACTIVE INGREDIENT24H4NWX5CO1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
29500-243829500-2438-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 82 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MINERAL OILMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
BENZYL BENZOATEBENZYL BENZOATEN863NB338GCAPSULE / ORALNAExact identifier — unii candidate
4 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4OINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE / ORAL13.75 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERYL OLEATEGLYCERYL OLEATE4PC054V79PCAPSULE / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
BENZYL BENZOATEBENZYL BENZOATEN863NB338GSOLUTION / INTRAMUSCULAR447 mgExact identifier — unii candidate
4 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COCAPSULE, DELAYED RELEASE PELLETS / ORAL234 mgExact identifier — unii candidate
13 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COCAPSULE, EXTENDED RELEASE / ORAL21 mgExact identifier — unii candidate
13 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
GLYCERYL OLEATEGLYCERYL OLEATE4PC054V79PSPRAY / TOPICAL0.95 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
CALCIUM PHOSPHATECALCIUM PHOSPHATE97Z1WI3NDXTABLET, COATED / ORAL93.6 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / VAGINAL140 mgExact identifier — unii candidate
21 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COTABLET, EXTENDED RELEASE / ORAL66 mgExact identifier — unii candidate
13 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii candidate
30 equally ranked IID candidates
GLYCERYL OLEATEGLYCERYL OLEATE4PC054V79PGEL / TOPICAL1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
COCOA BUTTERCOCOA BUTTER512OYT1CRRSUPPOSITORY / RECTAL2280 mgExact identifier — unii candidate
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUPPOSITORY / RECTAL35 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii candidate
30 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
13 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4GRANULE, FOR SUSPENSION / ORAL4 mgExact identifier — unii candidate
21 equally ranked IID candidates
CALCIUM PHOSPHATECALCIUM PHOSPHATE97Z1WI3NDXPASTE, DENTIFRICE / DENTAL45.93 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii candidate
30 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COPOWDER / TOPICAL10056 mgExact identifier — unii candidate
13 equally ranked IID candidates
CALCIUM PHOSPHATECALCIUM PHOSPHATE97Z1WI3NDXTABLET, FILM COATED / ORAL858 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COTABLET, COATED / ORAL52.44 mgExact identifier — unii candidate
13 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, DELAYED RELEASE / ORAL15 mgExact identifier — unii candidate
21 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, EXTENDED RELEASE / ORAL529 mgExact identifier — unii candidate
21 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COTABLET / ORAL150 mgExact identifier — unii candidate
13 equally ranked IID candidates
CALCIUM PHOSPHATECALCIUM PHOSPHATE97Z1WI3NDXPOWDER, DENTIFRICE / DENTAL0.11 mg/mgExact identifier — unii candidate
6 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COSYRUP / ORAL10 mg/1mlExact identifier — unii candidate
13 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM PHOSPHATECALCIUM PHOSPHATE97Z1WI3NDXTABLET, EXTENDED RELEASE / ORAL352.63 mgExact identifier — unii candidate
6 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COTABLET, DELAYED RELEASE / ORAL18.5 mgExact identifier — unii candidate
13 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii candidate
30 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii candidate
21 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
BENZYL BENZOATEBENZYL BENZOATEN863NB338GINJECTION, SOLUTION / INTRAMUSCULAR750 mgExact identifier — unii candidate
4 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
CALCIUM PHOSPHATECALCIUM PHOSPHATE97Z1WI3NDXTABLET / ORAL183.94 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / TOPICAL3.27 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET / ORAL33.34 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERYL OLEATEGLYCERYL OLEATE4PC054V79PPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
21 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ab1ce5cf-f5ca-05f4-e053-2995a90ae8baa0e3b500-1295-47cd-ab4e-503f51895bbb2020-07-23WarningsExact identifier
spl id: ab1ce5cf-f5ca-05f4-e053-2995a90ae8ba
spl set id: a0e3b500-1295-47cd-ab4e-503f51895bbb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.