Your browser does not support JavaScript! NEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]
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NEUROMED 7 TOPICAL PAIN RELIEF (lidocaine hydrochloride) cream
[Sambria Pharmaceuticals, LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

NeuroMed 7 Topical Pain Relief Cream


Active Ingredients

Lidocaine HCl (4.00%)

Purpose

External Anesthetic

Uses:

For temporary relief of pain and itching and minor skin irritations due to minor cuts and scrapes, sunburn and minor burns. Also used for temporary relief of itching associated with minor skin irritations and rashes due to insect bites, poison ivy, poison oak and poison sumac, soaps, detergents, cosmetics and jewelry.

Warnings:

- For external use only.

- Avoid contact with eyes.

- If symptoms persists for more than seven days, or clear up and occur again within a few days, discontinue use and consult physician.

- If redness, irritation, swelling, pain or other symptoms increase, discontinue and consult a physician.

Keep out of reach of children.

If swallowed, consult physician.

Directions:

For adults and children two-years or older, apply externally to the affected area. Do not use more than three or four times per day.

Other ingredients:

Aqua (Deionized Water), Arnica Montana Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonyl Methane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine.

NeuroMed 7 Topical Pain Relief Cream 2.2oz/63g (54723-175-22)

Neuro Med7 Label ANeuro Med7 Label B

NEUROMED 7 TOPICAL PAIN RELIEF 
lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54723-175
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ARNICA MONTANA 
C13-14 ISOPARAFFIN 
CHONDROITIN SULFATE (BOVINE) 
EMU OIL 
DIETHYLENE GLYCOL MONOETHYL ETHER 
ETHYLHEXYLGLYCERIN 
GLUCOSAMINE SULFATE 
ISOPROPYL PALMITATE 
LAURETH-7 
DIMETHYL SULFONE 
PHENOXYETHANOL 
PROPYLENE GLYCOL 
STEARIC ACID 
TROLAMINE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54723-175-221 in 1 CARTON
163 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/15/2013
Labeler - Sambria Pharmaceuticals, LLC (078676259)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source Inc.969241041manufacture(54723-175)

Revised: 8/2013
 
Sambria Pharmaceuticals, LLC

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