Base Laboratories Numb Gel

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Prieinama:

JOONEM LLC

Vartojimo būdas:

TOPICAL

Recepto tipas:

OTC DRUG

Terapinės indikacijos:

Temporary relieves minor pain

Autorizacija statusas:

OTC monograph not final

Prekės savybės

BASE LABORATORIES NUMB GEL- LIDOCAINE, MENTHOL GEL
JOONEM LLC
_Disclaimer: 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._
----------
BASE LABORATORIES NUMB GEL
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Lidocaine 4%
Menthol 1%
_PURPOSE_
Topical Analgesic
_INDICATIONS:_
Temporary relieves minor pain
_WARNINGS:_
Avoid contact with the eyes. If condition worsens, or if symptoms
persist for more than
7 days or clear up and occur again within a few days, discontinue use
of this product
and consult a physician.
Do not apply to wounds or damaged skin.
Do not bandage tightly.
DO NOT USE
in large quantities, particularly over raw surfaces or blistered
areas.
KEEP OUT OF REACH OF CHILDREN TO AVOID ACCIDENTAL INGESTION!
If swallowed, get medical help or contact the poison control center
immediately.
_DIRECTIONS:_
use only as directed
adults and children 12 years of age and older: apply to affected area
not more than 3
to 4 times daily
children under 12 years of age: consult a doctor
_OTHER INFORMATION:_
Store at 20 to 25C (68 to 77 F)
_INACTIVE INGREDIENTS:_
Glycerol, Propylene Glycol, Alcohol, GPL, Hydroxyethyl Cellulose,
Water
PACKAGE LABELING:
BASE LABORATORIES NUMB GEL
lidocaine, menthol gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:80327-007
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
LIDOCAINE
40 mg in 1 mL
JOONEM LLC
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
MENTHOL
10 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
LIQUEFIED PETROLEUM GAS (UNII: 5K616HU99V)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1