LIDOCAINE PAIN RELIEF- lidocaine hcl cream 
ASTONEA LABS PRIVATE LIMITED

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ASTONEA LIDOCAINE 4 % CREAM

Active ingredients

Lidocaine HCl 4%

Purpose

Lidocaine HCl - 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
  • do not get into eyes
  • do not bandage tightly or apply external heat (such as a heating pad) 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
  • redness, rash, or irritation occurs

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center (800-222-1222) right away.

Directions

Inactive ingredients

aloe vera leaf, carbomer 940, ceteth-20, cetostearyl alcohol, dimethicone, glycerin. glyceryl monostearate, isopropyl alcohol, petrolatum, phenoxyethanol, polysorbate 60, trolamine, water

Package/Label Principal Display Panel

Principal Display and Drug Fact Panel

LIDOCAINE PAIN RELIEF 
lidocaine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
TROLAMINE (UNII: 9O3K93S3TK)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-009-0476.5 g in 1 TUBE; Type 0: Not a Combination Product03/12/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01703/12/2024
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Revised: 3/2024
Document Id: 137d58e3-83f0-c0b8-e063-6294a90a6802
Set id: 137d4608-8b39-f1bf-e063-6294a90a162c
Version: 1
Effective Time: 20240312
 
ASTONEA LABS PRIVATE LIMITED