HealthWise Pain Relief Cream with 4% Lidocaine

HealthWise Pain Relief Cream with Lidocaine by

Drug Labeling and Warnings

HealthWise Pain Relief Cream with Lidocaine by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, Nantong Health & Beyond Hygienic Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTHWISE PAIN RELIEF CREAM WITH LIDOCAINE- lidocaine hydrochloride cream 
Veridian Healthcare

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

HealthWise Pain Relief Cream with 4% Lidocaine

HealthWise Pain Relief Cream with 4% Lidocaine, 1.75 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

alcohol, aloe vera leaf, aminomethylpropanol, carbomer interpolymer type a, cyclomethicone 5, dihexadecyl phosphate, dimethicone, dimethicone/vinyl dimethicone crosspolymer, edetate disodium, ethylhexylglycerin, glyceryl monostearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, steareth-21, water

PRINCIPAL DISPLAY PANEL

HEALTHWISE PAIN RELIEF CREAM WITH LIDOCAINE 
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-932
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)
ALCOHOL (UNII: 3K9958V90M)
ISOHEXADECANE (UNII: 918X1OUF1E)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
STEARETH-21 (UNII: 53J3F32P58)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-932-01	1 in 1 CARTON	12/01/2022
1		49.6 g in 1 BOTTLE, PLASTIC; 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	12/01/2022

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc		421280161	manufacture(71101-932)

Revised: 12/2022

Document Id: ef176d33-10ba-ddb2-e053-2995a90a76e3

34390-5

Set id: ef176d33-10b9-ddb2-e053-2995a90a76e3

Version: 1

Effective Time: 20221205