OTC Medication Information: TheraCare 4% Lidocaine Cream

THERACARE 4% LIDOCAINE CREAM- lidocaine hydrochloride 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.

TheraCare 4% Lidocaine Cream. 2.7 oz

Drug Facts

Active ingredient

Lidocaine HCI 4%

Purpose

Lidocaine HCl 4%…………………………………………………………………………………………………………….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 warning 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 (1-800-222-1222) right away.

Directions

adults and children over 12 years:

■ apply a thin layer to the 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

aloe vera leaf, carbopol 940, cetostearyl alcohol, dimethicone 350, edetate disodium, glycerin, glyceryl monostearate, isopropyl alcohol, phenoxyethanol, polysorbate 60, steareth 2, steareth 21, water

PRINCIPAL DISPLAY PANEL

label
(click image for full-size original)

THERACARE 4% LIDOCAINE CREAM
lidocaine hydrochloride cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71101-933
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
ISOPROPYL ALCOHOL
CETOSTEARYL ALCOHOL
CARBOMER 940
DIMETHICONE 350
STEARETH-2
POLYSORBATE 60
GLYCERYL MONOSTEARATE
ALOE VERA LEAF
GLYCERIN
PHENOXYETHANOL
STEARETH-21
EDETATE DISODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71101-933-01 1 TUBE in 1 CARTON contains a TUBE
1 76.5 g in 1 TUBE This package is contained within the CARTON (71101-933-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 12/01/2022
Labeler — Veridian Healthcare (830437997)
Establishment
Name Address ID/FEI Operations
ANICARE PHARMACEUTICALS PRIVATE LIMITED 916837425 manufacture (71101-933)

Revised: 12/2022 Veridian Healthcare

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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