FDA.reportPublic FDA data

Family Wellness Anorectal Lidocaine Cream

Manufacturer
FAMILY DOLLAR (Family Wellness)
Effective date
2024-11-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:38:34

Label at a glance#

ProductFamily Wellness Anorectal Lidocaine
Active ingredientLIDOCAINE
Label structure10 sections

Indications and uses

Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Dosage and administration

When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 6 times a day. Children under 12 years of age: consult a doctor. To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer...

Label contents#

Full prescribing information#

Active ingredient 

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5 % w/w

Purpose 

OTC - PURPOSE SECTION

Local Anesthetic

Uses

INDICATIONS & USAGE SECTION

Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Warnings 

WARNINGS SECTION

For external use only.

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if 

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days

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.

Directions 

DOSAGE & ADMINISTRATION SECTION

  • When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
  • Children under 12 years of age: consult a doctor.
  • To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

Other information 

OTHER SAFETY INFORMATION

Store at controlled room temperature 68-77° F (20-25 °C)

Inactive ingredient

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, Vitamin E Acetate

Principal display panel -Tube 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Family Wellness         NDC 55319-826-28

HEMORRHOIDAL CREAM 

Lidocaine 5%

NET WT 1 OZ (28.3g)

FD_AnorLido_TubeFD_AnorLido_Tube

Principal Display Panel -Carton 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Family Wellness NDC 55319-826-28

HEMORRHOIDAL CREAM

Lidocaine 5%

NET WT 1 OZ (28.3g)

FD_AnorLido_CartonFD_AnorLido_Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN3
1366789lidocaine 50 MG/ML Rectal CreamSCD3
1366789lidocaine 5 % Rectal CreamSY3

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-826-28Family Wellness Anorectal Lidocaine28.3 g in 1 TUBECREAM28.33
55319-826-28Family Wellness Anorectal Lidocaine1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-826FAMILY WELLNESS ANORECTAL LIDOCAINE (ANORECTAL LIDOCAINE) CREAM [FAMILY DOLLAR (FAMILY WELLNESS)]3Current NDC, 2 package rows20241122_ed7e0cdc-ca4b-47ba-b82b-49fb4913ef8d.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-82655319-826-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
TROLAMINE9O3K93S3TKIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
POLYSORBATE 806OZP39ZG8HIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHOLESTEROL97C5T2UQ7JIACT
WATER059QF0KO0RIACT

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
Family Wellness Anorectal LidocaineANORECTAL LIDOCAINEFAMILY DOLLAR (Family Wellness)ed7e0cdc-ca4b-47ba-b82b-49fb4913ef8d2024-11-21WarningsExact identifier
ndc (package): 55319-826-28
ndc (product): 55319-826
ndc11 (package): 55319082628
spl id: a1fbbda3-f05b-4db2-856d-f7e5471c91ca
spl set id: ed7e0cdc-ca4b-47ba-b82b-49fb4913ef8d

Reported adverse events (FAERS/openFDA)#

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