QUALITY CHOICE PAIN RELIEF 4% LIDOCAINE CREAM- lidocaine hydrochloride cream 
Chain Drug Marketing Association, Inc.

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Quality Choice Pain Relief Cream

Quality Choice 4% Lidocaine Cream. 2.7 oz

Drug Facts

Active ingredient

Lidocaine HCI 4%

Purpose

Lidocaine HCl 4%............................................................................................................................Topical anesthetic

Use

temporarily relieves minor pain

Warnings

For external use only

Avoid contact with eyes

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 warning 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.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

adults and children over 12 years:

■ apply a thin layer to the affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period

■ children 12 years or younger: ask a doctor

Inactive ingredients

aloe vera leaf, carbopol 940, cetostearyl alcohol, dimethicone 350, edetate disodium, glycerin, glyceryl monostearate, isopropyl alcohol, phenoxyethanol, polysorbate 60, steareth 2, steareth 21, water

Other Information

■ Store at room temperature

PRINCIPAL DISPLAY PANEL

label

QUALITY CHOICE PAIN RELIEF 4% LIDOCAINE CREAM 
lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
STEARETH-2 (UNII: V56DFE46J5)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARETH-21 (UNII: 53J3F32P58)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83324-006-271 in 1 CARTON04/01/2023
176.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01704/01/2023
Labeler - Chain Drug Marketing Association, Inc. (011920774)
Establishment
NameAddressID/FEIBusiness Operations
Astonea Labs Private Label878533295manufacture(83324-006)

Revised: 3/2024
Document Id: 14813b84-feaa-f04f-e063-6394a90abd4a
Set id: fa191676-681a-32c6-e053-6394a90a937f
Version: 3
Effective Time: 20240325
 
Chain Drug Marketing Association, Inc.