WHITE FLOWER ANALGESIC BALM- camphor, menthol, and methyl salicylate oil

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Available from:

JELMA PHILIPPINES INC

Administration route:

TRANSDERMAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose External analgesic Uses For the temporary relief of minor aches and pains of muscles and joints due to - simple backache - arthritis - strains - bruises - sprains Do not use - on wounds - on irritated or damaged skin - on the face - otherwise than as directed Stop use and ask a doctor if - condition worsens - symptoms persist for more than 7 days - symptoms clear up and occur again within a few days - excessive irritation of the skin develops - nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs - when using for pain of arthritis - pain persists for more than 10 days redness is present in conditions affecting children under 12 years of age - pain persists for more than 10 days - redness is present - in conditions affecting children under 12 years of age

Authorization status:

OTC monograph not final

Summary of Product characteristics

WHITE FLOWER ANALGESIC BALM- CAMPHOR, MENTHOL, AND METHYL SALICYLATE
OIL
JELMA PHILIPPINES INC
_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._
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DRUG FACTS
ACTIVE INGREDIENTS
Camphor 6%
Menthol 15%
Methyl salicylate 40%
PURPOSE
External analgesic
USES For the temporary relief of minor aches and pains of muscles and
joints due to
simple backache
arthritis
strains
bruises
sprains
DO NOT USE
on wounds
on irritated or damaged skin
on the face
otherwise than as directed
WARNINGS
For external use only
WHEN USING THIS PRODUCT
avoid contact with the eyes or mucous membranes
do not bandage tightly
STOP USE AND ASK A DOCTOR IF
condition worsens
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive irritation of the skin develops
nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
when using for pain of arthritis
pain persists for more than 10 days
redness is present
in conditions affecting children under 12 years of age
KEEP OUT OF REACH OF CHILDREN TO AVOID ACCIDENTAL POISONING.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
Adults and children 3 years of age and older: Apply a few drops then
gently rub into the affected
area not more than 3 to 4 times daily.
Children under 3 years of age: Do not use, consult your doctor.
Refer to the above warnings; use otherwise than as directed may be
dangerous.
OTHER INFORMATION
keep container tightly closed
store at 15º to 30ºC (59º to 86ºF)
INACTIVE INGREDIENTS
Eucalyptus oil, lavender oil and peppermint oil.
QUESTIONS OR COMMENTS? [phone] M-F 9am to 5pm
you may also report serious side effects to this phone number
WHITE FLOWER ANALGESIC BALM NDC-51681-0001-1 0.67 fl oz (20mL)
WHITE FLOWER ANALGESIC BALM
camphor, menthol, and methyl salicylate oil
JELMA PHILIPPINES INC
PRODUCT INFORMATION
PRODUCT T YPE