FDA.reportPublic FDA data

FORMULA H

Manufacturer
Biological Health Group Corporation | Deserving Health International Corp
Effective date
2015-06-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:42:48

Label at a glance#

ProductFORMULA H
Active ingredientGLYCERIN
Label structure13 sections

Indications and uses

Helps relieve hemorrhoids

Dosage and administration

Apply to the affected area up to 6 times daily or after each bowel movement.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Glycerin 25%

PURPOSE

OTC - PURPOSE SECTION

Protectant

USES

INDICATIONS & USAGE SECTION

  • Helps relieve hemorrhoids

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply to the affected area up to 6 times daily or after each bowel movement.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Aloe Vera, Arnica, Sweet Almond Oil, Horse Chestnut Seed Extract, Ginkgo Biloba Leaf Extract, Evening Primrose Oil, Apricot Kernel Oil, Rose Hips Extract, Tea Tree Essential Oil, Grapefruit Seed Extract

WARNINGS

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

When using this product • do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • condition worsens
  • symptoms last more than 7 days, or clear up and occur again within a few days, consult a doctor.
  • In case of bleeding, consult a doctor promptly.

When using

OTC - WHEN USING SECTION

  • Do not exceed the recommended daily dosage unless directed by a doctor. Do not put this product into the rectum by using fingers or any mechanical device or applicator.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box 50mLBox 50mL

Label 50mLLabel 50mL

Box 15mLBox 15mL

Label 15mLLabel 15mL

DO NOT USE

OTC - DO NOT USE SECTION

Do not use if you are allergic to plants of the Asteraceae/ Compositae/Daisy family. Hypersensitivity, such as allergy, has been known to occur; in which case, discontinue use.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1654725glycerin 25 % Topical CreamPSN1
1654725glycerin 250 MG/ML Topical CreamSCD1
1654725glycerin 25 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69711-007-032020-01-31C16284748780-19d75b9d0-9ed1-f424-e053-dadaa90a57ceFORMULA H BALM – BÁLSAMO
69711-007-042020-01-31C16284748780-19d75b9d0-9ed1-f424-e053-dadaa90a57ceFORMULA H BALM – BÁLSAMO

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69711-007-03FORMULA H15 mL in 1 JARCREAM151
69711-007-03FORMULA H1 in 1 CARTONCREAM11
69711-007-04FORMULA H1 in 1 CARTONCREAM11
69711-007-04FORMULA H50 mL in 1 JARCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69711-007FORMULA H (GLYCERIN 25%) CREAM [BIOLOGICAL HEALTH GROUP CORPORATION]1Legacy NDC, 4 package rows20150620_18e6fa9a-444d-3da9-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OX1
GLYCERINACTIVE MOIETYPDC6A3C0OX1
ALMOND OILINACTIVE INGREDIENT66YXD4DKO91
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
APRICOT KERNEL OILINACTIVE INGREDIENT54JB35T06A1
ARNICA MONTANAINACTIVE INGREDIENTO80TY208ZW1
CITRUS PARADISI SEEDINACTIVE INGREDIENT12F08874Y71
EVENING PRIMROSE OILINACTIVE INGREDIENT3Q9L08K71N1
GINKGOINACTIVE INGREDIENT19FUJ2C58T1
HORSE CHESTNUTINACTIVE INGREDIENT3C18L6RJAZ1
ROSA CANINA FRUIT OILINACTIVE INGREDIENTCR7307M3QZ1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69711-00769711-007-04, 69711-007-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANAO80TY208ZWIACT
ALMOND OIL66YXD4DKO9IACT
HORSE CHESTNUT3C18L6RJAZIACT
GINKGO19FUJ2C58TIACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
APRICOT KERNEL OIL54JB35T06AIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
TEA TREE OILVIF565UC2GIACT
CITRUS PARADISI SEED12F08874Y7IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXACTIB

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 · 1 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALMOND OILALMOND OIL66YXD4DKO9CREAM / TOPICAL2 %w/wExact identifier — unii candidate

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
18e6fa9a-444e-3da9-e054-00144ff88e8818e6fa9a-444d-3da9-e054-00144ff88e882015-06-19WarningsExact identifier
spl id: 18e6fa9a-444e-3da9-e054-00144ff88e88
spl set id: 18e6fa9a-444d-3da9-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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