BALM STICK- camphor, menthol, methyl salicylate stick

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Kjøp det nå

Last ned Preparatomtale (SPC)
27-12-2021

Aktiv ingrediens:

Methyl Salicylate  7%, Menthol  13%, Camphor  12%

Tilgjengelig fra:

Indo Abadi Sari Makmur, PT

Administreringsrute:

TOPICAL

Resept typen:

OTC DRUG

Indikasjoner:

Methyl Salicylate     External Analgesic Menthol         External Analgesic Camphor    External Analgesic Relieves muscle pains, lumbago, insect bites, itching

Autorisasjon status:

OTC monograph not final

Preparatomtale

                                BALM STICK- CAMPHOR, MENTHOL, METHYL SALICYLATE STICK
INDO ABADI SARI MAKMUR, PT
_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._
----------
INDO ABADI SARI MAKMUR, PT
ACTIVE INGREDIENTS
Methyl Salicylate 7%
Menthol 13%
Camphor 12%
PURPOSE
Methyl Salicylate External Analgesic
Menthol External Analgesic
Camphor External Analgesic
USES
Relieves muscle pains, lumbago, insect bites, itching
DIRECTIONS
Apply to the affected area as needed.
WARNINGS
External Use Only. Do not use for children below 2 years of age. Avoid
direct application
into the nostrils.
WARNINGS
Keep out of reach of children.
WARNINGS
Stop use and ask 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, vomitting, abdominal discomfort, diarrhea, or skin rash occurs
When using for pain of arthritis: pain persits for more than 10 days,
redness is present,
in conditions affecting children 12 years of age.
OTHER INFORMATION
Keep container tightly closed. Store at 16 to 30 degrees centigrade
(69 to 86 Farenheit).
INACTIVE INGREDIENTS
Eucalyptus Oil, Capsicum, Peppermint Oil, Borneol
DRUG FACTS
BALM STICK
camphor, menthol, methyl salicylate stick
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:70815-001
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID -
UNII:O414PZ4LPZ)
METHYL SALICYLATE
7 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
MENTHOL
13 g
in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) -
UNII:5TJD82A1ET)
CAMPHOR
(SYNTHETIC)
12 g
in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
EUCALYPTUS OIL (UNII: 2R04ONI662)
CAPSICUM (UNII: 00UK7646FG)
PEPPERMINT OIL (UNII: AV092KU4JH)
BORNEOL (UNII: M89NIB437X)

                                
                                Les hele dokumentet