HOT AND COLD CREAM WITH LIDOCAINE- RA PAIN RELIEVING- lidocaine hcl and menthol cream

Hot and Cold Cream with Lidocaine- RA by

Drug Labeling and Warnings

Hot and Cold Cream with Lidocaine- RA by is a Otc medication manufactured, distributed, or labeled by Velocity Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

HOT AND COLD CREAM WITH LIDOCAINE- RA   PAIN RELIEVING
lidocaine hcl and menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76168-309
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.4 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.1 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76168-309-30	1 in 1 CARTON	05/25/2017
1		76.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/25/2017

Labeler - Velocity Pharma LLC (962198409)

Registrant - Velocity Pharma LLC (962198409)

Establishment
Name	Address	ID/FEI	Business Operations
SOTAC PHARMACEUTICALS PRIVATE LIMITED		876894019	manufacture(76168-309)