LIDOCAINE PAIN RELIEVING CREME- lidocaine hydrochloride cream

Lidocaine Pain Relieving Creme by

Drug Labeling and Warnings

Lidocaine Pain Relieving Creme by is a Otc medication manufactured, distributed, or labeled by SOTAC PHARMACEUTICALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Lidocaine Pain Relieving Creme

Drug Facts

Active ingredient

Lidocaine HCI 4%

Purpose

Topical anesthetic

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 carton.
  
• do not allow contact with the eyes
  
• do not bandage or apply local heat (such as heating pads) to the area of use

Stop use and ask a doctor if

• condition worsens
  
• symptoms persist for more than 7 days or clear up and occur again within a few days

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

children 12 years and 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.

Outer Label

INGREDIENTS AND APPEARANCE

LIDOCAINE PAIN RELIEVING CREME 
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72351-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 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, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
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: 72351-004-00	72 in 1 CASE	05/31/2018
1		133.24 g in 1 BOTTLE; 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	03/03/2017

Labeler - SOTAC PHARMACEUTICALS PRIVATE LIMITED (876894019)