NEPTUNE ICE- lidocaine, menthol, camphor, and dimethicone gel

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941), DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O), LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Dostupné s:

A-S Medication Solutions

Podání:

TOPICAL

Druh předpisu:

OTC DRUG

Terapeutické indikace:

Topical Anesthetic Topical Analgesic Topical Analgesic Skin Conditioner For the temporary relief of joint pain and muscle pain associated with: - Arthritis - Backache - Discomfort - Cramps - Neckache - Soreness - Sprains - Strains

Přehled produktů:

Product: 50090-4640 NDC: 50090-4640-0 89 mL in a TUBE, WITH APPLICATOR

Stav Autorizace:

OTC monograph not final

Charakteristika produktu

NEPTUNE ICE- LIDOCAINE, MENTHOL, CAMPHOR, AND DIMETHICONE GEL
A-S MEDICATION SOLUTIONS
_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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NEPTUNE ICE
METHEMOGLOBINEMIA
Cases of methemoglobinemia have been reported in association with
local anesthetic
use. Although all patients are at risk for methemoglobinemia, patients
with glucose-6-
phosphate dehydrogenase deficiency, congenital or idiopathic
methemoglobinemia,
cardiac or pulmonary compromise, infants under 6 months of age, and
concurrent
exposure to oxidizing agents or their metabolites are more susceptible
to developing
clinical manifestations of the condition. If local anesthetics must be
used in these
patients, close monitoring for symptoms and signs of methemoglobinemia
is
recommended.
Signs and symptoms of methemoglobinemia may occur immediately or may
be delayed
some hours after exposure and are characterized by a cyanotic skin
discoloration and
abnormal coloration of the blood. Methemoglobin levels may continue to
rise; therefore,
immediate treatment is required to avert more serious central nervous
system and
cardiovascular adverse effects, including seizures, coma, arrhythmias,
and death.
Discontinue lidocaine-containing products and any other oxidizing
agents. Depending on
the severity of the symptoms, patients may respond to supportive care,
i.e., oxygen
therapy, hydration. More severe symptoms may require treatment with
methylene blue,
exchange transfusion, or hyperbaric oxygen
DRUG FACTS
ACTIVE INGREDIENT
Lidocaine 4%
PURPOSE
Topical Anesthetic
ACTIVE INGREDIENT
Menthol 1%
PURPOSE
Topical Analgesic
ACTIVE INGREDIENT
Camphor 3%
PURPOSE
Topical Analgesic
ACTIVE INGREDIENT
Dimethicone 3%
PURPOSE
Skin Conditioner
USES:
For the temporary relief of joint pain and muscle pain associated
with:
Arthritis
Backache
Discomfort
Cramps
Neckache
Soreness
Sprains
Strains
WARNINGS
FOR EXTERNAL US