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NDC 71101-0930-01 TheraCare 4% Lidocaine Cream 4 g/100g Details

TheraCare 4% Lidocaine Cream 4 g/100g

TheraCare 4% Lidocaine Cream is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Veridian Healthcare. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	71101-0930
Product ID	71101-930_c8088c02-49f7-4d04-e053-2995a90ab9e3
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	TheraCare 4% Lidocaine Cream
Proprietary Name Suffix	n/a
Non-Proprietary Name	LIDOCAINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	4
Active Ingredient Units	g/100g
Substance Name	LIDOCAINE HYDROCHLORIDE
Labeler Name	Veridian Healthcare
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71101-0930-01 (71101093001)

Pricing Information	N/A
NDC Package Code	71101-930-01
Billing NDC	71101093001
Package	1 BOTTLE, PLASTIC in 1 CARTON (71101-930-01) / 49.6 g in 1 BOTTLE, PLASTIC
Marketing Start Date	2021-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c808aa05-9d49-cc9f-e053-2a95a90a50f3 Details

Active ingredient

Lidocaine HCl 4%

Purpose

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 warnings on this carton.
do not allow contact with the eyes and mucus membranes
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 (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

Alcohol, Aloe Vera Leaf, Aminomethylpropanol, Carbomer Interpolymer Type A, Cyclopentasiloxane 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 TheraCare 4% Lidocaine Cream

INGREDIENTS AND APPEARANCE

THERACARE 4% LIDOCAINE CREAM

lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71101-930
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)
STEARETH-21 (UNII: 53J3F32P58)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM (UNII: 7FLD91C86K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71101-930-01	1 in 1 CARTON	07/01/2021
1		49.6 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 not final	part348	07/01/2021

Labeler - Veridian Healthcare (830437997)

Name	Address	ID/FEI	Business Operations
Establishment
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(71101-930)

Revised: 7/2021

Document Id: c8088c02-49f7-4d04-e053-2995a90ab9e3

Set id: c808aa05-9d49-cc9f-e053-2a95a90a50f3

Version: 1

Effective Time: 20210726