RADIAURA SKIN RECOVERY- lidocaine hcl - hydrocortisone acetate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

PureTek Corporation

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

The product is used for the anti-inflammatory and anesthetic relief of redness, pain, itching, and discoloration due to inflammation and skin burns. For the relief of redness, pain, itching, discoloration, inflammation and mild skin burns associated with radiation. For use after radiation treatment, cosmetic procedures, sun exposure, and for inflammatory skin conditions. Product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with “caine” ester type anesthetics. If excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician. Product and topical lidocaine should be used cautiously in those with impaired liver function, as well as the very ill or very elderly and those with significant liver disease. Product should be used with caution in patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive and ge

Product summary:

Radiaura Skin Recovery Cream (Lidocaine HCl 3% - Hydrocortisone Acetate 0.5%) is supplied as a beige cream 3 oz. (85 g) tube - NDC 59088-432-07

Authorization status:

unapproved drug other

Summary of Product characteristics

RADIAURA SKIN RECOVERY- LIDOCAINE HCL - HYDROCORTISONE ACETATE CREAM
PURETEK CORPORATION
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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RADIAURA® SKIN RECOVERY CREAM
RADIAURA SKIN RECOVERY CREAM
LIDOCAINE HCI 3% - HYDROCORTISONE ACETATE 0.5%
ANTI-INFLAMMATORY ANESTHETIC FOR RELIEF OF SKIN INFLAMMATION
Radiaura Skin Recovery Cream was specifically formulated by well-known
Radiation
Oncologist Dr. Lauren Lukas MD. This unique formulation is indicated
for relief of
redness, pain, itching, and discoloration associated with inflammation
and skin burns.
For use after radiation treatment, cosmetic procedures, sun exposure,
and for
inflammatory skin conditions.
The main ingredients in Radiaura Skin Recovery Cream include lidocaine
hydrochloride
(HCl) 3% and hydrocortisone acetate 0.5%, as well as botanicals
including curcumin
(from turmeric), tetrahydrocurcumin (tetrahydrodiferuloylmethane,
tetrahydrodemethoxydiferuloylmethane,
tetrahydrobisdemethoxydiferuloylmethane -
these are metabolites of curcumin from turmeric), boswellia serrata,
copper-tripeptide,
arbutin, calendula, camellia sinensis (green tea leaf extract), and
cucumis sativus
(cucumber extract). It also includes ChitoClear® chitosan which
serves as a silicone
substitute.
DESCRIPTION:
Lidocaine is chemically designated as acetamide,
2-(diethylamino)-N-(2,6-
dimethylphenyl), and has the following structure:
Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione,
21-(acetyloxy)-
11, 17-dihydroxy-(11β)-, It has the following structural formula:
RADIAURA SKIN RECOVERY CREAM LIDOCAINE HCL 3%- HYDROCORTISONE ACETATE
0.5% Each gram contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 5
mg.
ACTIVE INGREDIENTS:
Lidocaine HCl 3% (30 mg)
Hydrocortisone Acetate 0.5% (5 mg).
INACTIVE INGREDIENTS:
Aqua (Purified Water), Arbutin, Bis(Tripeptide-1) Copper Acetate,
Bisabolol, Boswellia
Serrata Extract, Brassica C