Active ingredient

Benzyl alcohol 10%

Lidocaine HCl 4%

Purpose

Topical anesthetic

Use

temporarily pain relief

Warnings

For external use only.

Do not use

on wounds or damaged skin
in large quantities
with a heating pad
if you are allergic to any ingredients of this product

When using this product

use only as directed.
avoid contact with eyes, mucous membranes or rashes
do not bandage tightly

Stop use and ask a doctor if

skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
condition worsens
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days 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 (800-222-1222) right away.

Directions

adults and children over 12 years:

clean and dry affected area
apply a thin layer to affected area not more than 3 to 4 times daily

children 12 years or younger: ask a doctor

Inactive ingredients

Aloe Vera Leaf, Aminomethyl propanol, butylene glycol, Carbomer Interpolymer Type A (allyl sucrose crosslinked), ceteth-10 phosphate, cetostearyl alcohol, dihexadecyl phosphate, dimethicone, glyceryl 1-stearate, hydroxyethyl acrylate/sodium acryloyl dimethyl taurate copolymer (100000 mPa.S at 1.5%), maltodextrin, polysorbate 80, SD alcohol, steareth-21, water

Other information

Avoid storing product in direct sunlight
Protect product from excessive moisture
Store with lid closed tightly

PRINCIPAL DISPLAY PANEL

label

HEALTHWISE LIDOCAINE PLUS CREAM
benzyl alcohol, lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71101-037
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH)	BENZYL ALCOHOL	10 g in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
STEARETH-21 (UNII: 53J3F32P58)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71101-037-01	1 in 1 CARTON	04/01/2024
1		85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	04/01/2024

Labeler - Veridian Healthcare (830437997)

Name	Address	ID/FEI	Business Operations
Establishment
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(71101-037)

HealthWise Lidocaine Plus Cream