PUREGEN LABS MAXIMUM STRENGTH LIDOCAINE- lidocaine cream

PUREGEN LABS Maximum Strength Lidocaine by

Drug Labeling and Warnings

PUREGEN LABS Maximum Strength Lidocaine by is a Otc medication manufactured, distributed, or labeled by Advanced Rx LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Lidocaine 5.00 %

Purpose

Anorectal (hemorrhoidal)

Uses

• Helps relieve the local itching and discomfort in the perianal area 
• For the temporary relief of pain, irritation” or burning.

Warnings:

For external use only

Do not

• exceed the recommended daily dosage unless directed by a doctor. 
• put this product into the rectum by using fingers or any mechanical device or applicator.

When using this product

• If the condition worsens or does not improve within 7 days, consult a doctor. 
• In case of bleeding, consult a doctor promptly.

Stop use and ask a doctor if

• If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Allergy alert 

• Certain persons can develop allergic reactions to ingredients in this product.

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use

Directions:

Adults:

• When practical, cleanse the affected area “with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad 
• Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. 
• Children under 12 years of age: consult a doctor. 
• Apply externally to the affected area up to 6 times daily or after each bowel movement.

Other information:

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Dimethyl Isosorbide, Ethylhexylglycerin, Ethylhexyl Stearate, Hydrogenated Polyisobutene, Lecithin, Phenoxyethanol, Propylene Glycol, Sodium Polyacrylate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Trideceth-6

Questions?

call toll-free 1-800-630-8895

Package Labeling:

INGREDIENTS AND APPEARANCE

PUREGEN LABS MAXIMUM STRENGTH LIDOCAINE 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-813
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
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIDECETH-6 (UNII: 3T5PCR2H0C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80513-813-06	170 g in 1 TUBE; Type 0: Not a Combination Product	04/22/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	04/22/2024

Labeler - Advanced Rx LLC (042795108)