FDA.reportPublic FDA data

Oxify Lidocaine 5% Cream

Manufacturer
Weeks & Leo Compnay, INC. | Weeks & Leo Co., Inc.
Effective date
2026-10-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-10-10 01:03:47

Label at a glance#

ProductOxify
Active ingredientLIDOCAINE
Label structure11 sections

Storage and handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controoled Room Temperature]

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% w/w

OTC - PURPOSE SECTION

Local anesthetic

OTC - QUESTIONS SECTION

Call 833-358-6431

WARNINGS SECTION

For External use only

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • symptoms being treated do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days

OTC - ASK DOCTOR SECTION

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • symptoms being treated do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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 over: apply externally to the affected area up to 6 times a day
  • children under 12 years: consult a doctor

INDICATIONS & USAGE SECTION

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

STORAGE AND HANDLING SECTION

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controoled Room Temperature]

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbedenisis (aloe vera) leaf juice, benzyl alcohol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl stearate, isopropyl myristate, methylparaben, propylene glycol, steareth – 21, tocopheryl acetate, trolamine, water

RECENT MAJOR CHANGES SECTION

Changed Administration section to dosage and administration section

updated a spelling error in Directions toiled to toilet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

Oxify

Lidocaine 5%

Anorectal (Hemorrhoidal) Cream

Relieves Pain, Itching, Burning

Net Wt. 6 oz (170 g)

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11383-33111383-331-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
DIMETHICONE 3502Y53S6ATLUIACT
GLYCERYL STEARATE230OU9XXE4IACT
DICETYL PHOSPHATE2V6E5WN99NIACT
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER4ZK9VP326RIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
METHYLPARABENA2I8C7HI9TIACT
CETETH-20 PHOSPHATE921FTA1500IACT
TROLAMINE9O3K93S3TKIACT
CETEARYL ALCOHOL2DMT128M1SIACT
CAPRYLYL METHICONEQ95M2P1KJLIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
STEARETH-2153J3F32P58IACT
WATER059QF0KO0RIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZYL ALCOHOLLKG8494WBHIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT

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 24 · 477 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flarestop Hemorrhoid LidocaineLIDOCAINEChelsea Pharmacceuticals LLCb8a589f7-7131-4807-9bcb-84af3078e2582026-09-10WarningsName fallback
generic name: LIDOCAINE
Pain Relieving Lidocaine PatchLIDOCAINEYYBA CORPaf8c84fd-224c-72b3-e053-2a95a90a95682026-09-07WarningsName fallback
generic name: LIDOCAINE
Lidocaine CreamLIDOCAINEInvaDerm Corporation5a7273d1-1dbc-420e-e063-6294a90a86292026-09-01WarningsName fallback
generic name: LIDOCAINE
LIDOCAINELIDOCAINEREMEDYREPACK INC.dfef4554-aeb4-4bdf-9557-648d3e84af3c2026-08-31Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
AnievaLCLIDOCAINEBlackstone Products, LLCddaba14c-10de-44e2-ae13-9217e20cb48e2026-08-29WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEA-S Medication Solutions3fbe48b5-128a-471c-8ecb-45e903b567402026-08-28Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
LAIYINHE Numbing Cream Anorectal (Hemorrhoidal) CreamLIDOCAINEGuangzhou Hechuang Commercial Service Co.,Ltd.59f0fa16-5eb0-e6bb-e063-6294a90aacf52026-08-26WarningsName fallback
generic name: LIDOCAINE
CVS Pain ReliefLIDOCAINECVS Pharmacy4ecbc263-e0d4-18d5-e063-6294a90a72e92026-08-26WarningsName fallback
generic name: LIDOCAINE
CVS Pain Relief Lidocaine XLLIDOCAINECVS Pharmacy4aa286e3-e274-8095-e063-6394a90ae8712026-08-26WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINESt. Mary's Medical Park Pharmacy9dc3059c-3a3d-5810-e053-2a95a90ab0ba2026-08-26Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
Lidocaine Pain ReliefLIDOCAINECardinal Health, 110 dba LEADER025d508b-ec4f-466c-b3e8-ba9b18d07b462026-08-26WarningsName fallback
generic name: LIDOCAINE
Foot Pain Relief PadsLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.5a18ff72-8a3e-5cdb-e063-6394a90a61622026-08-25WarningsName fallback
generic name: LIDOCAINE
LidocaineLIDOCAINEAmneal Pharmaceuticals LLC960f6d0a-82af-45e9-89d5-cea808004ebb2026-08-25Warnings, Adverse reactionsName fallback
generic name: LIDOCAINE
Big Toe Joint Pain Relief PatchLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.59c8ff98-55c7-796d-e063-6394a90af73a2026-08-24WarningsName fallback
generic name: LIDOCAINE
Lidocaine Numbing CreamLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.599b425a-0e96-76df-e063-6394a90a48ff2026-08-21WarningsName fallback
generic name: LIDOCAINE
Rugby PAIN RELIEF PATCHESLIDOCAINERUGBY LABORATORIESb34e40c8-a257-46cf-9399-f55df9b4102d2026-08-20WarningsName fallback
generic name: LIDOCAINE
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC58c2b35c-e1ed-7ea8-e063-6294a90a14942026-08-19WarningsName fallback
generic name: LIDOCAINE
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC585e740b-e4fa-d2aa-e063-6294a90a09822026-08-19WarningsName fallback
generic name: LIDOCAINE
Gembooxt Topical Numbing CreamLIDOCAINEGuangdong Quadrant Ecological Technology Co., Ltd.49951a3e-3b62-3d66-e063-6294a90a93602026-08-12WarningsName fallback
generic name: LIDOCAINE
Numbing CreamLIDOCAINE100 KARMA INC35b5ba9d-da1d-55d6-e063-6294a90a5fa82026-08-12WarningsName fallback
generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

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