PAIN RELIEF- lidocaine and menthol cream 
Genuine Virgin Aloe Corporation

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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ACTIVE INGREDIENT

LIDOCAINE 4%

MENTHOL 1.25%

TOPICAL ANESTHETIC

Temporarily relieves minor pain, itching and irritation due to/associated with:

  • ARTHRITIS
  • SIMPLE BACKACHE
  • MUSCLE STRAINS
  • SPRAINS
  • BRUISES
  • MINOR CUTS/SCRAPES
  • MINOR BURNS/SUNBURN
  • INSECT BITES

FOR EXTERNAL USE ONLY

DO NOT USE

  • IF YOU ARE ALLERGIC TO ANY TYPE OF NUMBING MEDICINE
  • IN LARGE QUANTITIES, PARTICULARLY OVER RAW SURFACES OR BLISTERED AREAS
  • ON INFECTIONS
  • ON DEEP PUNCTURE WOUNDS
  • ON RAW SURFACES OR BLISTERED AREAS

WHEN USING THIS PRODUCT

  • DO NOT USE OVER LARGE SKIN AREAS
  • DO NOT APPLY HEAT, BANDAGES OR PLASTIC WRAP TO TREATED AREAS
  • DO NOT USE IN OR NEAR THE EYES
  • WASH HANDS IMMEDIATELY AFTER USING

STOP USE AND ASK A DOCTOR IF

  • ALLERGIC REACTION OCCURS
  • CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS
  • SYMPTOMS CLEAR UP AND RETURN WITHIN A FEW DAYS
  • REDNESS, IRRITATION, SWELLING, PAIN OR OTHER SYMPTOMS BEGIN OR INCREASE.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS:

  • APPLY EXTERNALLY TO THE AFFECTED AREA UP TO 3 TO 4 TIMES A DAY. FOR USE ON ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER. CHILDREN UNDER 2 YEARS - ASK A DOCTOR.

Inactive ingredients: allantoin, aloe barbadensis (AP4® genuine virgin organic aloe vera) leaf extract, arnica montana flower extract, boswellia serrata gum, butyrospermum parkii (shea butter), calophyllum tacamahaca fruit (tamanu nut) oil, carbomer, cetearyl alcohol, chamomilla recutita matricaria (chamomile) extract, glyceryl stearate, hypericum perforatum (st. john’s wort), isopropyl palmitate, persea gratissima (avocado) oil, phenoxyethanol, polysorbate-60, sodium polyacrylate, squalane, stearyl alcohol, trideceth-6

DO NOT USE

  • IF PREGNANT OR BREAST FEEDING

Pain Relief Cream 2 2 oz carton

PAIN RELIEF 
lidocaine and menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10738-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALLANTOIN (UNII: 344S277G0Z)  
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)  
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
SHEA BUTTER (UNII: K49155WL9Y)  
CALOPHYLLUM TACAMAHACA WHOLE (UNII: 179EAP33MM)  
CARBOMER 934 (UNII: Z135WT9208)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHAMOMILE (UNII: FGL3685T2X)  
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SQUALANE (UNII: GW89575KF9)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10738-201-541 in 1 BOX01/03/2014
1NDC:10738-201-1262 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/03/201406/01/2018
Labeler - Genuine Virgin Aloe Corporation (961374147)
Registrant - Genuine Virgin Aloe Corporation (961374147)

Revised: 1/2021
 
Genuine Virgin Aloe Corporation