THERACARE 4% LIDOCAINE CREAM- lidocaine hydrochloride cream

TheraCare 4% Lidocaine Cream by

Drug Labeling and Warnings

TheraCare 4% Lidocaine 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]

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/01/2021

Labeler - Veridian Healthcare (830437997)

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