MedPath

Blue-Emu Lidocaine Pain Relief Cream

Blue-Emu Lidocaine Pain Relief Cream

Approved
Approval ID

592811f2-e21c-6a58-e053-2991aa0a69a9

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 9, 2025

Manufacturers
FDA

Kingsway Pharmaceuticals dba NFI, LLC

DUNS: 121681919

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

lidocaine cream 4%

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69993-350
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
lidocaine cream 4%
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 9, 2025
FDA Product Classification

INGREDIENTS (21)

LIDOCAINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: V13007Z41A
Classification: ACTIR
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
DIMETHICONE, UNSPECIFIEDInactive
Code: 92RU3N3Y1O
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
EMU OILInactive
Code: 344821WD61
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
SODIUM POLYACRYLATE (8000 MW)Inactive
Code: 285CYO341L
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
PEG-100 MONOSTEARATEInactive
Code: YD01N1999R
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYSORBATE 85Inactive
Code: A7F3N56197
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/20/2024

Principal Display Panel – Carton Label

NERVE DESENSITIZING
PAIN RELIEF CREAM

BLUE-EMU**®******


****Fast Acting
Odor Free
+ Emu Oil

Lidocaine
Pain Relief

Hands-Free
SOFT SPONGE
APPLICATOR

NEW!
Easy Open
Cap Design

AMERICA'S
#1
EMU OIL FORMULA
ODOR
FREE

Contains Emu Oil
****NET WT 2.7 OZ (77g)

image-01

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/20/2024

Use

temporarily relieves minor pain

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/20/2024

Active ingredient

Lidocaine HCl 4%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/20/2024

Purpose

Topical anesthetic

WARNINGS SECTION

LOINC: 34071-1Updated: 2/5/2025

Warnings

For external use only

Do not use

on large areas of the body or on cut, irritated or damaged 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 and pets.**If swallowed, get medical help or contact Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/20/2024

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

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 12/20/2024

Other information

Store at 68-77oF (20-25oC)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/5/2025

Inactive ingredients

acrylates/acrylamide copolymer, aloe barbadensis leaf juice (aloe vera), allantoin, caprylic capric triglyceride, cetyl alcohol, dimethicone, ethylhexylglycerin, emu oil, glycerin, glyceryl stearate, mineral oil, panthenol, phenoxyethanol, polyethylene glycol 100 stearate, polysorbate 80, polysorbate 85, sodium polyacrylate, stearic acid, triethanolamine, tocopherol acetate (Vitamin E), water.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 2/5/2025

Child-resistant packaging.
Close cap securely between uses.


****DISTRIBUTED BY:NFI CONSUMER PRODUCTS
501 Fifth Street • Bristol, TN 37620 • 1-800-432-9334
WWW.BLUE-EMU.COM

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