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Bunnies Bum Anorectal Numbing

Approved
Approval ID

3712e151-d171-1c5d-e063-6294a90a36c0

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 8, 2025

Manufacturers
FDA

FloCal Distributors LLC

DUNS: 128775688

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lidocaine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84308-173
Application NumberM015
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 8, 2025
FDA Product Classification

INGREDIENTS (14)

LIDOCAINEActive
Quantity: 5 g in 100 g
Code: 98PI200987
Classification: ACTIB
CARBOMER 940Inactive
Code: 4Q93RCW27E
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
CHAMOMILEInactive
Code: FGL3685T2X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CUCUMBERInactive
Code: YY7C30VXJT
Classification: IACT
DISODIUM COCOAMPHODIPROPIONATEInactive
Code: 6K8PRP397M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/2/2025

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/5/2024

Helps relieve the local itching and pain associated with anorectal disorders or inflammation.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/5/2024

Lidocaine 5%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/5/2024

Topical anesthetic

WARNINGS SECTION

LOINC: 34071-1Updated: 6/2/2025

For external use only.

**Flammable.**Keep away from excessive heat or open flame.

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this into the rectum by using fingers or any mechanical device or applicator
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 7/5/2024

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/5/2024

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/2/2025
  • When practical, cleanse the affected area with mild soap and warm water, rinse thoroughly and gently pat dry. Spray affected area, wash hands after 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.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/2/2025

Alcohol denat., aloe barbadensis leaf extract, carbomer, chamomilla recutita (matricaria) flower extract, cucumis sativus (cucumber) fruit extract, disodium cocoamphodipropionate, disodium EDTA, glycerin, propylene glycol, tocopheryl acetate, triethanolamine, water.

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Bunnies Bum Anorectal Numbing - FDA Drug Approval Details