UBER NUMB TOPICAL ANESTHETIC- lidocaine hydrochloride cream

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Compra

Scarica Scheda tecnica (SPC)
10-11-2023

Principio attivo:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)

Commercializzato da:

UberScientific, LLC

Via di somministrazione:

TOPICAL

Tipo di ricetta:

OTC DRUG

Indicazioni terapeutiche:

For the temporary relief of local pain and discomfort associated with anorectal disorders.

Stato dell'autorizzazione:

OTC monograph final

Scheda tecnica

                                UBER NUMB TOPICAL ANESTHETIC- LIDOCAINE HYDROCHLORIDE CREAM
UBERSCIENTIFIC, LLC
----------
UBER NUMB TOPICAL ANESTHETIC CREAM
DRUG FACTS:
ACTIVE INGREDIENT:
Lidocaine HCl 5.00%
Local Anesthetic
USES:
For the temporary relief of local pain and discomfort associated with
anorectal
disorders.
WARNINGS:
For external use only. Use only as directed.
WHEN USING THIS PRODUCT,
do not exceed the recommended daily dosage unless directed by a
doctor.
DO NOT INSERT
this product into rectum using fingers or any mechanical device.
KEEP OUT OF REACH OF CHILDREN.
Children under 12 should consult physician prior to use.
STOP USING THIS PRODUCT IF:
Symptoms worsen or does not improve within seven days
Bleeding occurs. Redness, irritation, swelling, pain or other symptoms
develop.
DIRECTIONS:
apply to affected area. ADULTS AND CHILDREN 12-YEARS AND OVER:
consult a physician before use. CHILDREN UNDER 12,
HOW TO APPLY:
Clean affected area with warm water nad mild soap. Rinse thoroughly.
Gently dry by patting with toilet tissue or soft cloth.
Apply externally to area up to six times per day.
OTHER INGREDIENTS:
Allantoin, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Propylene
Glycol, Sodium
Polyacrylate, Tocopheryl Acetate (Vitamin E), Triethanolamine.
Store at room temperature. Avoid direct sunlight
PACKAGE LABELING:
UBER NUMB TOPICAL ANESTHETIC
lidocaine hydrochloride cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:71131-774
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE -
UNII:98PI200987)
LIDOCAINE
50 mg
in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:71131-774-
                                
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