REFILL 3- benzalkonium chloride, lidocaine hydrochloride cream

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y), LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)

Dostępny od:

CMC Group Inc.

Droga podania:

TOPICAL

Typ recepty:

OTC DRUG

Wskazania:

- First aid to help prevent infection in minor cuts, scrapes, and burns. - For the temporary relief of pain and itching associated with minor burns , minor cuts, and scrapes

Status autoryzacji:

OTC monograph not final

Charakterystyka produktu

REFILL 3- BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE CREAM
CMC GROUP INC.
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REFILL 3
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Benzalkonium chloride 0.13%
Lidocaine hydrochloride 0.5%
PURPOSE
First aid antiseptic
Pain relieving cream
USES
First aid to help prevent infection in minor cuts, scrapes, and burns.
For the temporary relief of pain and itching associated with minor
burns , minor cuts,
and scrapes
_WARNINGS_
For external use only.
_DO NOT USE_
• in the eyes • over large areas of the body • in large
quantities • over raw surfaces or
blistered areas • longer than 1 week unless directed by a doctor
ASK A DOCTOR BEFORE USE IF YOU HAVE
• deep or puncture wounds • animal bites • serious burns.
STOP USE AND ASK A DOCTOR IF
• the condition persists or gets worse • symptoms persist for more
than 7 days or clear
up and occur again within a few days
KEEP OUT OF REAH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
Clean the affected area
Adults and children 2 years of age and older: Apply a small amount of
this product to
affected area not more than 3 times daily
Children under 2 years of age: consult a doctor
May be covered with a sterile bandage
_OTHER INFORMATION_
Store at room temperature
_INACTIVE INGREDIENTS_
glycerin monostearate, glycerol, purified water
PACKAGE LABELING:
REFILL 3
benzalkonium chloride, lidocaine hydrochloride cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:49687-0017
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6JUD5X6Y)
BENZ ALKONIUM
CHLORIDE
0.13 g
in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE -
UNII:98PI200987)
LIDOCAINE
HYDROCHLORIDE
0.5 g
in 100 g
CMC Group Inc.
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DAT