HOT AND COLD CREAM WITH LIDOCAINE PAIN RELIEVING- lidocaine hcl and menthol cream 
Velocity Pharma LLC

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 Pain Relieving Cream with Lidocaine: Family Wellness

Drug Facts

HOT AND COLD CREAM with LIDOCAINE- Family Wellness

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:

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)

Untitled

HOT AND COLD CREAM WITH LIDOCAINE  PAIN RELIEVING
lidocaine hcl and menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-605
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.4 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-2 (UNII: 7H8VAM7778)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
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:76168-605-501 in 1 CARTON03/16/2020
149.6 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 finalpart34803/16/2020
Labeler - Velocity Pharma LLC (962198409)

Revised: 3/2020
Document Id: a0fc3a04-3086-d594-e053-2a95a90a84ce
Set id: a0fc4119-cb44-d580-e053-2a95a90a9cea
Version: 1
Effective Time: 20200316
 
Velocity Pharma LLC