HemAway

Manufacturer
Melaleuca, Inc.
Effective date
2010-12-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:33:12

Label at a glance#

ProductHemAway
Active ingredientLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves pain, itching and discomfort due to anorectal disorders and temporarily shrinks hemorrhoidal tissue.

WARNINGS SECTION

Warnings

For External use only

Allergy alert: Certain persons can develop allergic reactions to ingredients in this product.

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
Stop use and ask a doctor if
  • Rectal bleeding occurs
  • Condition worsens or does not improve within 7 days
  • Allergic reaction occurs
  • Symptoms clear up and return within a few days
  • Redness, irritation, swelling, pain or other symptoms begin or increase
Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

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

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

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults: when practical, cleanse the affected area with mild soap and warm water. Rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • Adults and children 12 years and older: apply externally to the affected area up to 4 times a day.
  • Children under 12 years of age: consult a doctor.

INFORMATION FOR PATIENTS SECTION

Other information

  • To secure child-resistant cap: screw cap tightly. Then turn cap in opposite direction. If clicking sound is not heard, repeat procedure.
  • Tamper-Evident: do not use if foil seal under cap is broken or missing.
  • See crimp of tube for lot number and expiration date.

INACTIVE INGREDIENT SECTION

Inactive ingredients:  Aloe Barbadensis Leaf Juice Extract, Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, vitamin E Acetate, Vitis Vinifera (Grape) Skin Extract

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                              Purpose
Lidocaine 5%...............................Local anesthetic
Phenylephrine HCI.........................Vasoconstrictor

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of boximage of box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1314141HemAway 5 % / 0.25 % Rectal CreamPSN1
1314136lidocaine 5 % / phenylephrine HCl 0.25 % Rectal CreamPSN1
1314141lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream [Hemaway]SBD1
1314136lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal CreamSCD1
1314141HemAway (lidocaine 5 % / phenylephrine hydrochloride 0.25 % ) Rectal CreamSY1
1314136lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal CreamSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
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05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-180-012020-01-31C16284748780-19d75b9d1-0ab9-f424-e053-dadaa90a57ce9e1f7343-17c7-45f8-963d-ba1a21d4b0f1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-180-01HemAway1 in 1 BOXCREAM11
54473-180-01HemAway28 g in 1 TUBECREAM281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-180HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]1Legacy NDC, 2 package rows20121007_9e1f7343-17c7-45f8-963d-ba1a21d4b0f1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI2009871
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
LIDOCAINEACTIVE MOIETY98PI2009871
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBH1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27E1
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7J1
GRAPEINACTIVE INGREDIENT6X543N684K1
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4N1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
TrolamineINACTIVE INGREDIENT9O3K93S3TK1
WaterINACTIVE INGREDIENT059QF0KO0R1

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
54473-18054473-180-01

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

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 5 · 275 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHTABLET, DELAYED RELEASE / ORAL2.31 mgExact identifier — unii candidate
50 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / INTRAVENOUS900 mgExact identifier — unii candidate
78 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAVENOUS242 mgExact identifier — unii candidate
50 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION / INTRAMUSCULAR5 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
9 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHCAPSULE, EXTENDED RELEASE / ORAL1.23 mgExact identifier — unii candidate
50 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HDROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
CHOLESTEROLCHOLESTEROL97C5T2UQ7JINJECTABLE, LIPOSOMAL / INFILTRATION0.47 %w/vExact identifier — unii candidate
10 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
78 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTERIAL0.9 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
78 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSLOTION / TOPICAL50 mgExact identifier — unii candidate
18 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRASYNOVIAL18 mgExact identifier — unii candidate
50 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii candidate
78 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / VAGINAL0.4 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HAEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii candidate
9 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCONCENTRATE / ORAL1 mg/1mlExact identifier — unii candidate
78 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / SUBCUTANEOUS0.95 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHCAPSULE / ORAL450 mgExact identifier — unii candidate
50 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRALESIONAL20 mgExact identifier — unii candidate
50 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / OPHTHALMIC8 mgExact identifier — unii candidate
78 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / SOFT TISSUE40 mgExact identifier — unii candidate
50 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRAVENOUS4680 mgExact identifier — unii candidate
78 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAVITREAL0.02 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, LIQUID FILLED / ORAL24 mgExact identifier — unii candidate
78 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSOIL / TOPICAL213 mgExact identifier — unii candidate
18 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS4739 mgExact identifier — unii candidate
78 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAVENOUS16624 mgExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLOTION / TOPICAL15 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
78 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRA-ARTICULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAVENOUS0.5 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
Benzyl AlcoholBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
50 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS53 mgExact identifier — unii candidate
78 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSPRAY / TOPICAL3665 mgExact identifier — unii candidate
18 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / AURICULAR (OTIC)0.2 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3FILM, EXTENDED RELEASE / TRANSDERMAL58.13 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
CHOLESTEROLCHOLESTEROL97C5T2UQ7JCREAM / VAGINAL0.3 %w/wExact identifier — unii candidate
10 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
7db048a3-6556-41d8-a5fe-b75e462d266e9e1f7343-17c7-45f8-963d-ba1a21d4b0f12010-12-06WarningsExact identifier
spl id: 7db048a3-6556-41d8-a5fe-b75e462d266e
spl set id: 9e1f7343-17c7-45f8-963d-ba1a21d4b0f1

Reported adverse events (FAERS/openFDA)#

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