MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE

Manufacturer: CVS Pharmacy | Pharma Pac, LLC
Effective date: 2010-07-16
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:28:48

Label at a glance#

ProductMINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE

Active ingredientMINERAL OIL, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients Purpose

Mineral Oil 46.8%.............................................Protectant
Pramoxine HCL 1%......................................... Pain Reliever
Zinc Oxide 12.5%............................................Protectant

Use s

- temporarily relieves these local symptoms associated with hemorrhoids and other anorectal disorders:
- pain - soreness - burning - itching
- temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues

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.

INDICATIONS & USAGE SECTION

Uses

- temporarily relieves these local symptoms associated with hemorrhoids and other anorectal disorders:
- pain - soreness - burning - itching
- temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues

Other information - store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F)

WARNINGS SECTION

Warnings

For external use only.

When using this product

- do not use more than directed unless told to do so by a doctor
- do not put into rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if
- allergic reaction occurs
- rectal bleeding occurs
- redness, irritation, swelling pain or other symptoms begin or increase
- condition worsens, or does not improve within 7 days

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

DOSAGE & ADMINISTRATION SECTION

Directions

Adults: apply externally to the affected area up to 5 times daily

- when practical, clean the affected area with mild soap and warn water and rinse thoroughly
- gently dry by patting or blotting with toilet tissue or soft cloth before applying
- to use dispensing cap:
- attach it to tube, lubricate well, then gently insert partway into anus
- squeeze tube to deliver medication
- thoroughly cleanse dispensing cap after use

Children under 12 years of age: ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients

benzyl benzonate, dicalcium phosphate, glyceryl oleate, glyceryl stearate,
kaolin, peruvian balsam, polyethylene, theobroma cacao (cocoa) seed butter

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59779-399-03	2019-10-29	C162847	48780-1	960f7f55-d0f7-8e05-e053-dbdaa90a074a	drug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59779-399-03	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE	28 g in 1 TUBE, WITH APPLICATOR	CREAM	28		1
59779-399-03	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE	1 in 1 CARTON	CREAM	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59779-399	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE CREAM [CVS PHARMACY]	1	Legacy NDC, 2 package rows	20110721_f15b86b3-8f6a-4a6e-9df4-24718e2751d4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	1
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	1
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	1
PRAMOXINE	ACTIVE MOIETY	068X84E056	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	1
BALSAM PERU	INACTIVE INGREDIENT	8P5F881OCY	1
BENZYL BENZOATE	INACTIVE INGREDIENT	N863NB338G	1
CALCIUM PHOSPHATE	INACTIVE INGREDIENT	97Z1WI3NDX	1
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	1
GLYCERYL MONOOLEATE	INACTIVE INGREDIENT	4PC054V79P	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE
MINERAL OIL
COCOA BUTTER
GLYCERYL MONOSTEARATE
GLYCERYL MONOOLEATE
KAOLIN
BALSAM PERU
BENZYL BENZOATE
CALCIUM PHOSPHATE
PRAMOXINE HYDROCHLORIDE
PRAMOXINE
ZINC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59779-399	59779-399-03

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
MINERAL OIL	T5L8T28FGP	ACTIB
COCOA BUTTER	512OYT1CRR	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
GLYCERYL MONOOLEATE	4PC054V79P	IACT
KAOLIN	24H4NWX5CO	IACT
BALSAM PERU	8P5F881OCY	IACT
BENZYL BENZOATE	N863NB338G	IACT
CALCIUM PHOSPHATE	97Z1WI3NDX	IACT
PRAMOXINE HYDROCHLORIDE	88AYB867L5	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB

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 1 · 52 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CALCIUM PHOSPHATE	CALCIUM PHOSPHATE	97Z1WI3NDX	TABLET, FILM COATED / ORAL		858 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	POWDER / TOPICAL		10056 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
COCOA BUTTER	COCOA BUTTER	512OYT1CRR	SUPPOSITORY / RECTAL	2280 mg		Exact identifier — unii candidate
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	GRANULE, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / SUBLINGUAL	1.23 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	CAPSULE / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
CALCIUM PHOSPHATE	CALCIUM PHOSPHATE	97Z1WI3NDX	TABLET, COATED / ORAL	93.6 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	TABLET, DELAYED RELEASE / ORAL	18.5 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	SYRUP / ORAL	10 mg/1ml		Exact identifier — unii candidate 13 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, EXTENDED RELEASE / ORAL	32.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	TABLET, EXTENDED RELEASE / ORAL	66 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, DELAYED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	EMULSION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	CAPSULE, DELAYED RELEASE PELLETS / ORAL		234 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
CALCIUM PHOSPHATE	CALCIUM PHOSPHATE	97Z1WI3NDX	TABLET, EXTENDED RELEASE / ORAL	352.63 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	SPRAY / TOPICAL	0.95 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / ORAL	33.34 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	FILM, EXTENDED RELEASE / TRANSDERMAL	18.8 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	CAPSULE, COATED PELLETS / ORAL		234 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / TOPICAL	3.27 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	TABLET / ORAL	150 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
CALCIUM PHOSPHATE	CALCIUM PHOSPHATE	97Z1WI3NDX	POWDER, DENTIFRICE / DENTAL	0.11 mg/mg		Exact identifier — unii candidate 6 equally ranked IID candidates
BENZYL BENZOATE	BENZYL BENZOATE	N863NB338G	CAPSULE / ORAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	TABLET / ORAL		3 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	TABLET, COATED / ORAL	52.44 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
CALCIUM PHOSPHATE	CALCIUM PHOSPHATE	97Z1WI3NDX	PASTE, DENTIFRICE / DENTAL	45.93 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / VAGINAL		140 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	CAPSULE, EXTENDED RELEASE / ORAL	21 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	GEL / TOPICAL	1 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
BENZYL BENZOATE	BENZYL BENZOATE	N863NB338G	SOLUTION / INTRAMUSCULAR		447 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
BENZYL BENZOATE	BENZYL BENZOATE	N863NB338G	INJECTION / INTRAMUSCULAR		1500 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
CALCIUM PHOSPHATE	CALCIUM PHOSPHATE	97Z1WI3NDX	TABLET / ORAL	183.94 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	CAPSULE / ORAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
BENZYL BENZOATE	BENZYL BENZOATE	N863NB338G	INJECTION, SOLUTION / INTRAMUSCULAR		750 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
GLYCERYL MONOOLEATE	GLYCERYL OLEATE	4PC054V79P	CREAM, AUGMENTED / TOPICAL	3.5 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE / ORAL	13.75 mg		Exact 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
de6ea099-3261-4190-9166-b98319cbbdc3			f15b86b3-8f6a-4a6e-9df4-24718e2751d4	2010-07-16	Warnings	Exact identifier spl id: de6ea099-3261-4190-9166-b98319cbbdc3 spl set id: f15b86b3-8f6a-4a6e-9df4-24718e2751d4

Reported adverse events (FAERS/openFDA)#

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