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← See all Hot and Cold Cream with Lidocaine- RA Pain Relieving brands

Hot and Cold Cream with Lidocaine- RA Pain Relieving

Dosage form: cream
Ingredients: LIDOCAINE 0.4g in 1g, MENTHOL 0.1g in 1g
Labeler: Velocity Pharma LLC
NDC Code: 76168-301

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.

Hot and Cold Pain Relieving 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

Uses

Temporarily relieves minor pain

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 this product
  • 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

Stop use and ask a doctor if
  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children and pets.

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

Directions

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 ingredients

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.

PRINCIPAL DISPLAY PANEL

Hot and cold Cream -RA
Lidocaine
Plus Menthol
Pain Relieving Cream
Net Wt 2.7 OZ (76.5 g)

HOT AND COLD CREAM WITH LIDOCAINE- RA   PAIN RELIEVING
lidocaine hcl and menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-301
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE0.4 g  in 1 g
MENTHOL (MENTHOL) MENTHOL0.1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
CETOSTEARYL ALCOHOL 
CETETH-2 
CETYL ALCOHOL 
EDETATE DISODIUM 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
LIGHT MINERAL OIL 
PROPYLENE GLYCOL 
SORBIC ACID 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:76168-301-301 TUBE in 1 CARTON
176.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/25/2017
Labeler - Velocity Pharma LLC (962198409)
Registrant - Velocity Pharma LLC (962198409)
Establishment
NameAddressID/FEIOperations
Yash Pharmaceuticals871409551manufacture(76168-301)

 
Velocity Pharma LLC

← See all Hot and Cold Cream with Lidocaine- RA Pain Relieving brands

Medically reviewed on May 25, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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