HealthWise 4% Lidocaine Pain Relief Roll-on

Active ingredient

Lidocaine 4%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain

Warnings

For external use only

When using this product

use only as directed. Read and follow all directions and warnings on this carton.
do not allow contact with the eyes and mucus membranes
do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
do not use at the same time as other topical analgesics

Stop use and ask a doctor if

condition worsens
redness is present
irritation develops
symptoms persist for more than 7 days or clear up and occur again within a few days

Flammable■ Keep away from fire or flame

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 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

acrylates/C10-30 alkyl acrylate crosspolymer (6000 MPA.S), capsaicin, glycerin, isopropyl myristate, propylene glycol, SD alcohol, triethanolamine, water

Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer (60000 MPA.S), aloe barbadensis leaf juice, aminomethyl propanol, ceteth-10 phosphate, cetostearyl alcohol, Cyclomethicone 5, dicetyl phosphate, dimethicone 350, dimethicone/vinyl dimethicone
crosspolymer (soft particle), disodium EDTA, ethylhexylglycerin, glyceryl 1 stearate, hydroxyethyl acrylate/sodium acryloyl dimethyl taurate copolymer (100000 MPA.S at 1.5%), isohexadecane,
phenoxyethanol, SD alcohol, steareth-21, water

Questions or comments

Call 1-866-326-1313

Principal Display Panel

label

HEALTHWISE ROLL-ON LIDOCAINE PAIN RELIEF LIQUID
lidocaine hci liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71101-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ISOHEXADECANE (UNII: 918X1OUF1E)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
ALCOHOL (UNII: 3K9958V90M)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LAVENDER OIL (UNII: ZBP1YXW0H8)
STEARETH-21 (UNII: 53J3F32P58)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71101-003-01	1 in 1 CARTON	02/01/2024
1		73 mL in 1 BOTTLE, WITH APPLICATOR; 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	01/02/2024

Labeler - Veridian Healthcare (830437997)

Name	Address	ID/FEI	Business Operations
Establishment
Nantong Health & Beyond Hygienic Products Inc		421280161	manufacture(71101-003)

HealthWise Roll-On Lidocaine Pain Relief Liquid