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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: 76168-400

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- DG Health

Drug Facts

HOT AND COLD CREAM with LIDOCAINE- DG Health

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 -DG Health
Lidocaine Plus Menthol
Pain Relieving Cream
Net Wt 1.75 OZ (49.6 g)

HOT AND COLD CREAM WITH LIDOCAINE- RA   PAIN RELIEVING
lidocaine hcl and menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-400
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:76168-400-311 TUBE in 1 CARTON
149.6 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/22/2018
Labeler - Velocity Pharma LLC (962198409)
Registrant - Velocity Pharma LLC (962198409)

Revised: 01/2018
 
Velocity Pharma LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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