Pain Relief Cream by Henan Enokon Medical Instrument Co., Ltd. PAIN RELIEF CREAM cream

Pain Relief Cream by

Drug Labeling and Warnings

Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by Henan Enokon Medical Instrument Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 4%

Purpose

Local Anesthetic

Use

For temporary relief of local discomfort,itching, pain,soreness or burning in the perianal area addociated with anorectal disorders.

Warnings

For external use only

Do not use

Avoid contact with eyes, if this happens, rinse thoroughly with water;
If conditions worsen or if symptoms persist for more than 7 days or clear up use and consult a physician. and occur again within a few days, discontinue
Do not use in large quantities, particularly over raw surfaces or blistered areas.

When Using

Do not exceed the recommended daily dosage unless directed by a doctoi
Do not put into the rectum by using fingers or any mechanical device or applicator.

Stop Use

If allergic reaction occurs, rectal bleeding occurs redness, irritation, swelling
pain or other symptoms begin or increase condition worsens or does not improve within 7 days.

Ask Doctor

If allergic reaction occurs, rectal bleeding occurs redness, irritation, swelling pain or other symptoms begin or increase condition worsens or does not improve within 7 days.

Keep Out Of Reach Of Children

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

Directions

1. Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application of the product.
2.Apply externally to the affected area up to 6 times daily.
3. Children under 12 years of age: consult a doctor.

Other information

1.Always keep the tube tightly closed.
2.Store at temperatures not exceeding 15'C-30℃ (59°F-86°F)
3.Protect from freezing.

Inactive ingredients

Menthol；Borneol；Triclosan；Glycyrrhizinate Dipotassium；Ethanol；Phenoxyethanol；Glycerin；Dimethicone；Laurocapram
；Purified Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF CREAM 
pain relief cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83559-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
LAUROCAPRAM (UNII: 1F3X9DRV9X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
BORNEOL (UNII: M89NIB437X)
TRICLOSAN (UNII: 4NM5039Y5X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83559-009-01	60 mL in 1 TUBE; Type 0: Not a Combination Product	05/30/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/30/2025

Labeler - Henan Enokon Medical Instrument Co., Ltd. (701730676)

Establishment
Name	Address	ID/FEI	Business Operations
Henan Enokon Medical Instrument Co., Ltd.		701730676	manufacture(83559-009)