Indications and uses
Temporarily relieves pain and itchingdue to anorectal disorders.
Active Ingredient
- Manufacturer
- InvaDerm Corporation
- Effective date
- 2026-09-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-09-03 03:01:49
Label at a glance#
ProductLidocaine Cream
Active ingredientLIDOCAINE
Label structure9 sections
Dosage and administration
When practical, clean affected 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: Ask a doctor.
Label contents#
Full prescribing information#
Active Ingredient
Lidocaine 5% W/W
Purpose
Local Anesthetic
Uses
Temporarily relieves pain and itchingdue to anorectal disorders.
Warnings
When using this product
- avoid contact with eyes
- do not exceed recommended dosage unless directed by a doctor
Stop use and ask a doctor if
- rectal bleeding occurs
- condition worsens or does not improve within 7 days
- allergic reaction occurs
- redness, irritation, swelling, pain or other symptoms begin 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
- When practical, clean affected 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: Ask a doctor.
Other Information
Store at room temperature 20-25 °C (68-77°F)
Excursions permitted 15-30 °C (59-86°F) [see USP Controlled Room Temperature]
Inactive ingredient
Benzyl Alcohol, Carbomer, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, Vitamin E Acetate
Principal Primary Panel - Carton
NDC 71457-525-15
Lidocaine 5%
Anorectal Cream
NET WT 15 grams
NDC 71457-525-30
Lidocaine 5%
Anorectal Cream
NET WT 30 grams
Products#
Every source-derived product name is available through these pages.
- Lidocaine Cream
- Lidocaine
- PROPYLENE GLYCOL
- HYDROGENATED SOYBEAN LECITHIN
- TROLAMINE
- ISOPROPYL MYRISTATE
- BENZYL ALCOHOL
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- POLYSORBATE 80
- .ALPHA.-TOCOPHEROL ACETATE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71457-525 | 71457-525-15, 71457-525-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LIDOCAINE | 98PI200987 | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| HYDROGENATED SOYBEAN LECITHIN | H1109Z9J4N | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE | 0A5MM307FC | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Lidocaine Cream | LIDOCAINE | InvaDerm Corporation | 5a7273d1-1dbc-420e-e063-6294a90a8629 | 2026-09-01 | Warnings | 71457-525-30 71457-525-15 71457-525 71457052530 71457052515 5a727400-ef10-23e5-e063-6394a90aec25 5a7273d1-1dbc-420e-e063-6294a90a8629 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.