PAINXIT- methyl salicylate, menthol cream

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Commercializzato da:

Asclemed USA, Inc

Via di somministrazione:

TOPICAL

Tipo di ricetta:

OTC DRUG

Indicazioni terapeutiche:

Topical Analgesic Topical Analgesic For temporary relief of minor aches and pains associated with simple backaches, arthritis, bruises, sprains and cramps.

Stato dell'autorizzazione:

OTC monograph not final

Scheda tecnica

PAINXIT- METHYL SALICYLATE, MENTHOL CREAM
ASCLEMED USA, 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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PAINXIT
DRUGS FACTS
ACTIVE INGREDIENTS
Methyl Salicylate………10.00%
Menthol…………………3.00%
PURPOSE
Topical Analgesic
Topical Analgesic
USES
For temporary relief of minor aches and pains associated with simple
backaches,
arthritis, bruises, sprains and cramps.
WARNING
FOR EXTERNAL USE ONLY.
Avoid contact with eyes and mucous membranes.
Do not bandage tightly or cover treated areas.
Do not use with heating pad.
Do not apply to open wounds or damages skin.
A mild burning sensation may occur. If severe burning sensation
occurs, discontinue
use immediately.
If symptoms persist for more than seven days, discontinue use and
consult physician.
KEEP OUT OF REACH OF CHILDREN. If swallowed, consult physician.
If pregnant or breast feeding, contact physician prior to use.
DIRECTIONS
For adults apply directly to affected area. Repeat as necessary, but
do not use more
than 3-4 times daily.
ADDITIONAL INFORMATION
Store at room temperature.
OTHER INGREDIENTS
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf
(Aloe Vera Gel)
Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea,
Isopropyl Myristate,
Methyl Paraben, PEG-8, Propyl Paraben, Propylene Glycol, Sodium lauryl
Sulfate,
Triethanolamine.
PRINCIPAL DISPLAY PANEL
NDC 76420-211-01
PAINXIT
PAIN RELIEF CREAM
4 oz (113.4g)
Distributed by:
ENOVACHEM
PHARMACEUTICALS
TORRANCE, CA 90501
[phone]
PAINXIT
methyl salicylate, menthol cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:76420-211
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID -
UNII:O414PZ4LPZ)
METHYL SALICYLATE
10 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL -