LIDOCAINE PLUS MAXIMUM STRENGTH PAIN RELIEVING CREAM- lidocaine hydrochloride cream 
Prime Enterprises Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Lidocaine Plus Maximum Strength Pain Relieving Cream

Active Ingredients

Lidocaine Hydrochloride 4%

Purpose

Pain Relieving Cream

Indications (Uses)

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

For external use only.

Avoid contact with the eyes.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Keep out of reach of children.

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

Directions

Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Carbomer, Diazolidinyl Urea, Disodium EDTA, DMDM Hydantoin, Fragrance, Menthol, Methylparaben, Polysorbate 20, Propylene Glycol, SD Alcohol 40-B, Triethanolamine, Water, Yellow 5

Other Information

Questions or Comments?

Call 1-888-263-9808

Lidocaine Plus Maximum Strength Pain Relieving Cream

Principal Display Image

LIDOCAINE PLUS  MAXIMUM STRENGTH PAIN RELIEVING CREAM
lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS39.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
LAURETH-7 (UNII: Z95S6G8201)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
WATER (UNII: 059QF0KO0R)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0123-3118 mL in 1 TUBE; Type 0: Not a Combination Product03/02/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/02/2007
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0123) , manufacture(58443-0123) , label(58443-0123) , analysis(58443-0123)

Revised: 7/2020
Document Id: aa8122dd-0266-12aa-e053-2a95a90aaf8e
Set id: 2c26e249-2659-6214-e054-00144ff88e88
Version: 3
Effective Time: 20200715
 
Prime Enterprises Inc.