THERACARE PAIN RELIEVING LIDOCAINE CREAM- lidocaine hydrochloride cream

TheraCare Pain Relieving Lidocaine Cream by

Drug Labeling and Warnings

TheraCare Pain Relieving Lidocaine Cream by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare , DermaCare Research Labs, LLC. 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

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylylmethicone, cetearyl alcohol, ceteth-20phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, methylparaben, steareth-21, water

PRINCIPAL DISPLAY PANEL TheraCare 4% Lidocaine Cream

INGREDIENTS AND APPEARANCE

THERACARE PAIN RELIEVING LIDOCAINE CREAM 
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-056
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)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
STEARETH-21 (UNII: 53J3F32P58)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DICETYL PHOSPHATE (UNII: 2V6E5WN99N)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-056-01	1 in 1 CARTON	02/01/2025
1		76.5 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	02/01/2025

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
DermaCare Research Labs, LLC		116817470	manufacture(71101-056)