Initial Drug Listing - Aemerry Numbing Cream-171

Manufacturer
Da Capo Prima LLC
Effective date
2026-04-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:56:52

Label at a glance#

ProductAemerry Numbing Cream
Active ingredientMENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

OTC - PURPOSE SECTION

Local Anesthetic

DOSAGE & ADMINISTRATION SECTION

Temporarily relieves local and anorectal discomfort associated with the anorectal disorder or swelling.

WARNINGS SECTION

For external use only

Do not use this product if

  • youare allergic to lidocaine.
  • in case of accidental overdose, seek immedidate medical help or contact the Poison Control Center.
  • seal is broken or missing.

When using this product

  • donot exceed the recommended daily dosage unless directed by a doctor. Certain sensitive individualsmayhave an allergic reaction to some of the ingredients of this product.
  • do not put this cream into the rectum using your fingers, applicators, or any medical devices.

Stop use and ask a doctor if

the symptom being treated does not improve, or ifredness,irritation, swelling, pain, or other symptoms appear or worsen. Seek medical help right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek medical help right away.

INDICATIONS & USAGE SECTION

  • Children(under 12 yearsof age):consult a doctor.
  • Adults: before applying this product, cleanthe affected area with mild soap andwarm water and rinsethoroughly.Pat drythe area with a soft cloth or tissue.
  • Apply up to 3 times a day.

OTHER SAFETY INFORMATION

  • Keep away from direct sunlight or heat.
  • Store at room temperature 59°-86°F (15°-30°C).

INACTIVE INGREDIENT SECTION

Aqua, Propylene Glycol, Carbomer 934, Lecithin(Soybean),Tocopheryl Acetate, Benzyl Alcohol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039690menthol 5 % Topical CreamPSN1
1039690menthol 50 MG/ML Topical CreamSCD1
1039690menthol 5 % Topical CreamSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87615-002-01Aemerry Numbing Cream50 g in 1 CARTONCREAM501

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87615-00287615-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
Aemerry Numbing CreamMENTHOL 5%Da Capo Prima LLC4fefddaf-19c8-86b4-e063-6294a90abffc2026-04-20WarningsExact identifier
ndc (package): 87615-002-01
ndc (product): 87615-002
ndc11 (package): 87615000201
spl id: 4fefddaf-19c9-86b4-e063-6294a90abffc
spl set id: 4fefddaf-19c8-86b4-e063-6294a90abffc

Reported adverse events (FAERS/openFDA)#

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