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NDC 71101-0931-01 TheraCare 4% Lidocaine and 1% Menthol Cream 4; 1 g/100g; g/100g Details

TheraCare 4% Lidocaine and 1% Menthol Cream 4; 1 g/100g; g/100g

TheraCare 4% Lidocaine and 1% Menthol Cream is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Veridian Healthcare. The primary component is LIDOCAINE; MENTHOL.

Product Information

NDC	71101-0931
Product ID	71101-931_c80ba263-3d5f-0953-e053-2a95a90ae80b
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 and 1% Menthol Cream
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol and Lidocaine
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	4; 1
Active Ingredient Units	g/100g; g/100g
Substance Name	LIDOCAINE; MENTHOL
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 71101-0931-01 (71101093101)

Pricing Information	N/A
NDC Package Code	71101-931-01
Billing NDC	71101093101
Package	1 BOTTLE in 1 CARTON (71101-931-01) / 49.6 g in 1 BOTTLE
Marketing Start Date	2021-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c80ba251-91a5-0858-e053-2995a90a9cff Details

Active ingredients

Lidocaine HCL

Menthol

Purposes

Lidocaine HCl 4%............................................................................................................................Topical anesthetic

Menthol 1%.......................................................................................................................................Topical analgesic

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

■ 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, not more than 6 to 8 hours, not 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 & 1% Menthol Cream

INGREDIENTS AND APPEARANCE

THERACARE 4% LIDOCAINE AND 1% MENTHOL CREAM

menthol and lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71101-931
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
STEARETH-21 (UNII: 53J3F32P58)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOHEXADECANE (UNII: 918X1OUF1E)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71101-931-01	1 in 1 CARTON	07/01/2021
1		49.6 g in 1 BOTTLE; 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(71101-931)

Revised: 7/2021

Document Id: c80ba263-3d5f-0953-e053-2a95a90ae80b

Set id: c80ba251-91a5-0858-e053-2995a90a9cff

Version: 1

Effective Time: 20210726