BLUE-EMU LIDOCAINE PAIN RELIEF CREAM- lidocaine cream 4% cream

Blue-Emu Lidocaine Pain Relief Cream by

Drug Labeling and Warnings

Blue-Emu Lidocaine Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by Nutrition & Fitness, Inc., DBA NFI Consumer Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine HCl 4%

Stop use and ask doctor if

• Condition worsens
• symptoms persist for more than 7 days or clear up and occur again in a few days

Keep out of reach of children and pets

If swallowed, get medical help or contact Poison Control Center right away.

Purpose

Topical analgesic

Warnings

For external use only

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 usig this product

Use only as directed. Read and follow all directions and warnings on the carton.

• do not allow contact with the eyes
• do not bandage or or apply local heat (such as heating pads) to the area of use.

If Pregnant or breast feeding

ask a health professional before use.

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

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

Uses

For the temporary relief of pain

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BLUE-EMU LIDOCAINE PAIN RELIEF CREAM 
lidocaine cream 4% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69993-350
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)
PANTHENOL (UNII: WV9CM0O67Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EMU OIL (UNII: 344821WD61)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-120 GLYCERYL STEARATE (UNII: 6941286E4I)
MINERAL OIL (UNII: T5L8T28FGP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYSORBATE 85 (UNII: A7F3N56197)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69993-350-03	1 in 1 CARTON	03/01/2017
1		77 in 1 TUBE; 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	03/01/2017

Labeler - Nutrition & Fitness, Inc., DBA NFI Consumer Products, Inc. (016785052)