OXIFY- lidocaine 5% cream

Oxify by

Drug Labeling and Warnings

Oxify by is a Otc medication manufactured, distributed, or labeled by Weeks & Leo Compnay, INC., Weeks & Leo Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 5% w/w

ASK DOCTOR

• 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

KEEP OUT OF REACH OF CHILDREN

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

PREGNANCY OR BREAST FEEDING

Ask a health professional before use.

PURPOSE

Local anesthetic

QUESTIONS

Call 833-358-6431

STOP USE

• 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

WHEN USING

• 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

WARNINGS

For External use only

DOSAGE & 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

STORAGE AND HANDLING

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

INDICATIONS & USAGE

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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OXIFY 
lidocaine 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11383-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
DICETYL PHOSPHATE (UNII: 2V6E5WN99N)
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
TROLAMINE (UNII: 9O3K93S3TK)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
STEARETH-21 (UNII: 53J3F32P58)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Product Characteristics
Color	white (off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11383-002-06	170 g in 1 JAR; Type 0: Not a Combination Product	10/31/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	10/31/2025

Labeler - Weeks & Leo Compnay, INC. (005290028)

Registrant - Weeks & Leo Compnay, INC. (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co., Inc.		005290028	manufacture(11383-002)