PAIN FREE IV- lidocaine cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)

Available from:

Sambria Pharmaceuticals, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

External Anesthetic For temporary relief of pain and itching due to minor skin irritations.

Authorization status:

OTC monograph not final

Summary of Product characteristics

PAIN FREE IV- LIDOCAINE CREAM
SAMBRIA PHARMACEUTICALS, LLC
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_DRUG FACTS_
_ACTIVE INGREDIENT_
4% Lidocaine
_PURPOSE_
External Anesthetic
_USES_
For temporary relief of pain and itching due to minor skin
irritations.
_WARNINGS_
FOR EXTERNAL USE ONLY.
AVOID CONTACT WITH EYES.
DO NOT USEin large quantities, particularly over raw surface or
blistered areas
STOP USE AND ASK DOCTOR IF
Condition worsens or if symptons persists more than 7 days or clear up
and occur
again within a few days. Discontinue use.
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
For adults and children two-years or older: Apply to affected area not
more than 3 or 4
times daily. Children under 2 years of age: consult a physician.
_INACTIVE INGREDIENTS_
Aqua (Deionized Water), Arnica Montana Floweri Extract, C13-14
Isoparaffin,
Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin,
Glucosamine Sulfate,
Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil,
Methylsulfonylmenthane (MSM), Phenoxyethanol, Polyacrylamide,
Propylene Glycol,
Stearic Acid, Triethanolamine.
_OTHER INFORMATION_
Protect this product from excessive heat and direct sun.
QUESTION OR COMMENTS
FDA Registered : [e-mail]
OTHER INFORMATION
PAIN FREE IV
lidocaine cream
Sambria Pharmaceuticals, LLC
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:54723-008
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
LIDOCAINE
4 g in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ELOSULFASE ALFA (UNII: ODJ69JZG85)
EMU OIL (UNII: 344821WD61)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LAURETH-7 (UNII: Z95S6G8201)