TheraCare 4% Lidocaine & 1% Menthol Cream

TheraCare 4% Lidocaine and 1% Menthol Cream by

Drug Labeling and Warnings

TheraCare 4% Lidocaine and 1% Menthol Cream 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]

THERACARE 4% LIDOCAINE AND 1% MENTHOL CREAM- menthol and lidocaine 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.

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TheraCare 4% Lidocaine & 1% Menthol Cream

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

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/01/2021

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(71101-931)

Revised: 7/2021

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

34390-5

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

Version: 1

Effective Time: 20210726