Signature Care Hemorrhoidal Ointment 1 oz (with applicator) 78982 ZDP

Manufacturer
Better Living Brands, LLC
Effective date
2026-02-05
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:36:42

Label at a glance#

ProductSignature Care Hemorrhoidal
Active ingredientPETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL
Label structure13 sections

Storage and handling

Other information store at 20-25°C (68-77°F) Lot No. & Exp. Date: see box or see crimp of tube

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                                               Purpose

Mineral oil 14%..............................................Protectant

Petrolatum 74.9%..........................................Protectant

Phenylephrine HCI 0.25%..........................Vasconstrictor

OTC - PURPOSE SECTION

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 bowel movements less painful

WARNINGS SECTION

Warnings

For external and/or intrarectal use only

OTC - ASK DOCTOR SECTION

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 of pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

OTC - WHEN USING SECTION

When using this product do not exceed the recommended daily dosage unless directed by a doctor.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • introduction of applicator into rectum causes additional pain

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Directions

  • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment.
  • when first opening the tube, puncture foil seal with top end of cap
  • apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement  
  • interacetal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into thoroughly cleanse applicator after each use and replace cover
  • also apply ointment to external area
  • regular use provides continual therapy for relief of symptoms
  • children under 12 years of age: ask a doctor

STORAGE AND HANDLING SECTION

Other information

  • store at 20-25°C (68-77°F)
  • Lot No. & Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT SECTION

Inactive ingredients

.alpha.-tocopherol acetate, alcohol, glycerin, lanolin, methylparaben, polysorbate 80, propylparaben, stearyl alcohol, thyme oil, purified water, white wax

DOSAGE & ADMINISTRATION SECTION

Distributed by:

Better Living Brands LLC

P.O. Box 99

Pleasanton, CA 94566-0009

1-888-723-3929

www.betterlivingbrandsLLC.com

Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

78982.178982.1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN7
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD7
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY7

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-130321130789826GTIN-13: 0321130789826
EAN-13: 0321130789826
GTIN-12: 321130789826
UPC-A: 321130789826
GTIN storage (14 digits): 00321130789826
78982.1.jpg
BarcodeEAN-130321131782826GTIN-13: 0321131782826
EAN-13: 0321131782826
GTIN-12: 321131782826
UPC-A: 321131782826
GTIN storage (14 digits): 00321131782826
78982.1.jpg
QR code linkQR Codealbtsn.com/ugtfm3978982.1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21130-789-142025-01-30C16284748780-12cef2736-b62b-d83d-e063-dadaa90ab31fSignature Care Hemorrhoidal Ointment 1 oz (with applicator) 78982 ZDP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-789-14Signature Care Hemorrhoidal1 in 1 CARTONOINTMENT17
21130-789-14Signature Care Hemorrhoidal28 g in 1 TUBEOINTMENT287

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-78921130-789-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
Signature Care HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCIBetter Living Brands, LLC3c8b43f3-6e1e-499e-ba71-ffdf836f67432026-02-05WarningsExact identifier
ndc (package): 21130-789-14
ndc (product): 21130-789
ndc11 (package): 21130078914
spl id: 4a197084-aa10-02ef-e063-6394a90a1e46
spl set id: 3c8b43f3-6e1e-499e-ba71-ffdf836f6743

Reported adverse events (FAERS/openFDA)#

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