CAMPHO-PHENIQUE ANTISEPTIC (camphor- synthetic and phenol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Camphor (synthetic) (UNII: 5TJD82A1ET) (Camphor (synthetic) - UNII:5TJD82A1ET), Phenol (UNII: 339NCG44TV) (Phenol - UNII:339NCG44TV)

Available from:

Foundation Consumer Healthcare

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/antiseptic - for temporary relief of pain and itching associated with minor burns sunburn minor cuts scrapes insect bites minor skin irritation - minor burns - sunburn - minor cuts - scrapes - insect bites - minor skin irritation - first aid to help protect against infection in minor cuts scrapes burns - minor cuts - scrapes - burns

Authorization status:

OTC monograph not final

Summary of Product characteristics

CAMPHO-PHENIQUE ANTISEPTIC- CAMPHOR (SYNTHETIC) AND PHENOL GEL
FOUNDATION CONSUMER HEALTHCARE
_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._
----------
CAMPHO-PHENIQUE
ANTISEPTIC GEL
_DRUG FACTS_
ACTIVE INGREDIENT
Camphorated phenol (camphor 10.8% and phenol 4.7%)
PURPOSES
Pain reliever/antiseptic
USES
for temporary relief of pain and itching associated with
minor burns
sunburn
minor cuts
scrapes
insect bites
minor skin irritation
first aid to help protect against infection in
minor cuts
scrapes
burns
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE
over large areas of the body
with a bandage
ASK A DOCTOR BEFORE USE IF YOU HAVE
a deep or puncture wound
animal bites
serious burns
WHEN USING THIS PRODUCT do not use in or near the eyes. If contact
occurs, rinse
®
eyes thoroughly with water and obtain medical attention.
STOP USE AND ASK A DOCTOR IF
condition worsens
symptoms persist for more than 7 days or clear up and occur again
within a few
days
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison
Control Center right away.
DO NOT INDUCE VOMITING before contacting medical help or a Poison
Control Center.
DIRECTIONS
adults and children 2 years of age and over:
clean the affected area
apply a small amount of this product on the area 1 to 3 times daily
do not bandage
children under 2 years of age: ask a doctor
OTHER INFORMATION
store at room temperature. Avoid excessive heat above 40°C (104°F).
close cap tightly after use
INACTIVE INGREDIENTS
light mineral oil, colloidal silicon dioxide, aloe barbadensis leaf
extract, glycerin,
eucalyptus oil
QUESTIONS OR COMMENTS?
1-855-602-2676 weekdays 9 AM to 5 PM EST
Distributed by:
Foundation Consumer Healthcare, LLC.
Pittsburgh, PA 15212
PRINCIPAL DISPLAY PANEL - 14 G TUBE CARTON
with
aloe
MAXIMUM STRENGTH
MEDICATED
CAMPHO
PHENIQUE
PAIN & ITCH RELIEF
ANTISEPTIC GEL
®
Multi-purpose formula
in