HOT AND COLD WITH LIDOCAINE-RA PAIN RELIEVING- lidocaine hcl and menthol cream 
SOTAC PHARMACEUTICALS PRIVATE LIMITED

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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Hot and Cold Cream with Lidocaine-RA

Drug Facts

HOT AND COLD CREAM with LIDOCAINE-RA
PAIN RELIEVING CREAM
Drug Facts

Active Ingredients

Lidocaine HCl 4%
Menthol 1%

Purposes

Lidocaine- Topical anesthetic,
Menthol- Topical Analgesic

WARNINGS

For external use only

DO NOT USE 
  • on large areas of the body or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

WHEN USING SECTION
  • Use only as directed. Read and follow all directions and warnings on this label
  • rare cases of serious burns have been reported with products of this type
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch
  • avoid contact with eyes and mucous membranes
  • a transient burning sensation may occur upon application but generally disappears in several days

If pregnant or breast-feeding,

ask a health professional before use.

 KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION 

adults and children over 12 years:

  • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
  • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

children 12 years or younger: ask a doctor

INACTIVE INGREDIENT SECTION

Butylated hydroxyl toluene,cetostearyl alcohol,cetomacrogol 1000,cetyl alcohol,disodium EDTA,disodium hydrogen phosphate,light liquid paraffin,propylene glycol,sorbic acid,transquitol P, white petroleum jelly
Keep Carton As It Contains Important Information
Close cap tightly between uses.

Outer Label

Temporarily relieves minor pain

Label

rite aid cream

HOT AND COLD WITH LIDOCAINE-RA  PAIN RELIEVING
lidocaine hcl and menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72351-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.4   in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1   in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-2 (UNII: 7H8VAM7778)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBIC ACID (UNII: X045WJ989B)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72351-003-00128 in 1 CASE05/25/2017
176.5 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/25/2017
Labeler - SOTAC PHARMACEUTICALS PRIVATE LIMITED (876894019)

Revised: 5/2018
Document Id: 6d81b3a7-8206-b194-e053-2a91aa0a3934
Set id: d4d7b654-700c-41ed-b77f-996d9f5c9ef4
Version: 2
Effective Time: 20180531
 
SOTAC PHARMACEUTICALS PRIVATE LIMITED