Oxify Lidocaine 5% Cream

Oxify Lidocaine 5% Cream
SPL v3
SPL
SPL Set ID 41d9d0b4-33e7-7e05-e063-6394a90a1011
Route
TOPICAL
Published
Effective Date 2026-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Alpha-tocopherol Acetate Dimethicone 350 Glyceryl Stearate Dicetyl Phosphate C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Aloe Barbadensis Leaf Juice Isopropyl Myristate Methylparaben Ceteth-20 Phosphate Trolamine Cetearyl Alcohol Caprylyl Methicone Edetate Disodium Anhydrous Steareth-21 Water Ethylhexylglycerin Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Propylene Glycol Benzyl Alcohol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-31
Description

Lidocaine 5% w/w

Medication Information

Warnings and Precautions

For External use only

Indications and Usage

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 toiled 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
Description

Lidocaine 5% w/w

Section 43683-2

Changed Administration section to dosage and administration section

Section 44425-7

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

Section 50565-1

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

Section 50566-9
  • 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
Section 50567-7
  • 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
Section 50569-3
  • 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
Section 51727-6

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate

Section 51945-4

Oxify

Lidocaine 5% Anorectal (Hemorrhoidal) Cream

Relieves Pain

Relieves Itch

Relieves Burning

Net Wt. 6 oz (170 g)

Section 53413-1

Call 833-358-6431

Section 53414-9

Ask a health professional before use.

Section 55105-1

Local anesthetic

Section 55106-9

Lidocaine 5% w/w

Section 60561-8

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

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)
  • when practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toiled 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
Warnings and Precautions (34071-1)

For External use only

Section 43683-2 (43683-2)

Changed Administration section to dosage and administration section

Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)
  • 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
Section 50567-7 (50567-7)
  • 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
Section 50569-3 (50569-3)
  • 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
Section 51727-6 (51727-6)

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate

Section 51945-4 (51945-4)

Oxify

Lidocaine 5% Anorectal (Hemorrhoidal) Cream

Relieves Pain

Relieves Itch

Relieves Burning

Net Wt. 6 oz (170 g)

Section 53413-1 (53413-1)

Call 833-358-6431

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Local anesthetic

Section 55106-9 (55106-9)

Lidocaine 5% w/w

Section 60561-8 (60561-8)

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

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:39.653517 · Updated: 2026-03-14T23:13:46.303627