CAREALL Hemorrhoidal

Manufacturer
New World Imports, Inc
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:18:54

Label at a glance#

ProductCAREALL Hemorrhoidal
Active ingredientMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

 helps relieve the local itching and discomfort associated with hemorrhoids  temporarily shrinks hemorrhoidal tissue and relieves burning  temporarily provides a coating for relief of anorectal discomforts  temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Dosage and administration

A dults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toliet tissue or a soft cloth before applying ointment INTRARECTAL USE: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace cover EXTER...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Purpose

OTC - PURPOSE SECTION

Active Ingredients Purposes
Mineral Oil 14%...................................................................Protectant
Petrolatum 74.9%................................................................Protectant
Phenylephrine HCl 0.25%...............................................Vasoconstrictor

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 (1-800-222-1222)

Uses

INDICATIONS & USAGE SECTION

 helps relieve the local itching and discomfort associated with hemorrhoids
 temporarily shrinks hemorrhoidal tissue and relieves burning
 temporarily provides a coating for relief of anorectal discomforts
 temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

WARNINGS SECTION

For external and/or intrarectal 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 arepresently 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
Stop use and ask a doctor if
▪ bleeding occurs ▪ condition worsens or does not improved within 7 days
▪ introduction of applicator into the rectum causes additional pain
If pregnant or breast-feeding, ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults:when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toliet tissue or a soft cloth before applying ointment

  • INTRARECTAL USE: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace cover
  • EXTERNAL USE: apply to affected area
  • Apply to affected areas up to 4 times daily

Children under 12 years of age: consult a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thyme oil, Vitamin E, white wax

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEM2 Carton ArtworkHEM2 Carton Artwork

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN5
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD5
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130085317008734GTIN-13: 0085317008734
EAN-13: 0085317008734
GTIN-12: 085317008734
UPC-A: 085317008734
GTIN storage (14 digits): 00085317008734
HEM2 Carton Artwork.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
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f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51824-079-02CAREALL Hemorrhoidal56 g in 1 TUBEOINTMENT565

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-079-02GM - Gram51824-07951d77c1c-dc7a-4085-a467-4467751bd01b12023-07-06

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51824-07951824-079-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

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
CAREALL HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLNew World Imports, Inc7913bd41-a606-4ca6-b69f-2717c2f54b072025-12-01WarningsExact identifier
ndc (package): 51824-079-02
ndc (product): 51824-079
ndc11 (package): 51824007902
spl id: 44ebacf3-52c3-4896-e063-6394a90ac447
spl set id: 7913bd41-a606-4ca6-b69f-2717c2f54b07

Reported adverse events (FAERS/openFDA)#

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