LIDONUMB- lidocaine 5% cream

Lidonumb by

Drug Labeling and Warnings

Lidonumb by is a Otc medication manufactured, distributed, or labeled by Rising Pharma Holdings, Inc., Elysium Pharmaceuticals Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Lidocaine 5% w/w

Purpose

Topical anesthetic

Uses

Temporarily relieves the pain and itching due to anorectal disorders.

Warnings

For external use only.

When using this product

• avoid contact with eyes
• do not use in large quantities, particularly over large surfaces or blistered areas
• do not exceed recommended dosage unless directed by a doctor
• do not put this product into the rectum by using fingers or any mechnical device or applicator.

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
• 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.

Directions

• When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product.
• 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.

Other Information

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

Inactive Ingredients

Benzyl alcohol, carbomer 940, hydrolysed soy lecithin, isopropyl myristate, polysorbate 80, propylene glycol, triethanolamine, vitamin E acetate, water

Questions or comments?

Call 1-844-474-7464

PRINCIPAL DISPLAY PANEL

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. lic. No.: G/25/1362

Issued: 12/2025

INGREDIENTS AND APPEARANCE

LIDONUMB 
lidocaine 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-353
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER 940 (UNII: 4Q93RCW27E)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-353-15	1 in 1 CARTON	12/18/2025
1		15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	12/18/2025

Labeler - Rising Pharma Holdings, Inc. (116880195)

Registrant - Elysium Pharmaceuticals Ltd (915664486)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Ltd		915664486	manufacture(57237-353) , analysis(57237-353) , label(57237-353) , pack(57237-353)