PUREGEN LABS MAXIMUM STRENGTH LIDOCAINE- lidocaine cream 
Advanced Rx LLC

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PUREGEN LABS Maximum Strength Lidocaine 5% Cream

Drug Facts

Active ingredients

Lidocaine 5.00 %

Purpose

Anorectal (hemorrhoidal)

Uses

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:

Other information:

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:

Label

PUREGEN LABS MAXIMUM STRENGTH LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-813
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80513-813-06170 g in 1 TUBE; Type 0: Not a Combination Product04/22/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01504/22/2024
Labeler - Advanced Rx LLC (042795108)

Revised: 4/2024
Document Id: 15cfdc73-c2f3-528e-e063-6394a90a07ae
Set id: f4f89582-49e6-424a-bea7-0694484a7c99
Version: 1
Effective Time: 20240411
 
Advanced Rx LLC