QUALITY CHOICE PAIN RELIEF 4% LIDOCAINE CREAM- lidocaine hydrochloride cream

Quality Choice Pain Relief 4% Lidocaine Cream by

Drug Labeling and Warnings

Quality Choice Pain Relief 4% Lidocaine Cream by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association, Inc., ANICARE PHARMACEUTICALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

QUALITY CHOICE PAIN RELIEF 4% LIDOCAINE CREAM 
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83324-006
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83324-006-27	1 in 1 CARTON	04/01/2023
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 Drug	M017	04/01/2023

Labeler - Chain Drug Marketing Association, Inc. (011920774)

Establishment
Name	Address	ID/FEI	Business Operations
Astonea Labs Private Label		878533295	manufacture(83324-006)