ZYLOTROL- lidocaine hcl 4%, menthol 1% gel

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

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Herunterladen Fachinformation (SPC)
16-10-2023

Wirkstoff:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)

Verfügbar ab:

Asclemed USA, Inc.

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

OTC DRUG

Anwendungsgebiete:

Purpose Topical Analgesic Uses For the temporary relief of pain. Do not use - in large quantities, particularly over raw surfaces, or blistered areas.

Berechtigungsstatus:

OTC monograph not final

Fachinformation

                                ZYLOTROL- LIDOCAINE HCL 4%, MENTHOL 1% GEL
ASCLEMED USA, INC.
----------
ZYLOTROL
_ACTIVE INGREDIENTS_
Lidocaine HCl 4%
Menthol 1%
_PURPOSE_
Topical Analgesic
_USES_
For the temporary relief of pain.
_WARNINGS_
FOR EXTERNAL USE ONLY not intended for ingestion.
DO NOT USE
in large quantities, particularly over raw surfaces, or blistered
areas.
WHEN USING THIS PRODUCT
Avoid contact with the eyes.
STOP USE AND ASK A DOCTOR IF
condition worsens, or if symtoms 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 Central
right away.
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
_DIRECTIONS_
Adults and children 2 years of age and older: Apply to affected area
not more than 3
to 4 times a daily.
Children under 2 years of age: consult a doctor.
_OTHER INFORMATION_
Store at 20-25
C (68-77
F) and protect from moisture.
_INACTIVE INGREDIENTS_
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),
Arnica Montana
Flower Extract, Boswellia Serrata Extract, Carbomer,
Ethylhexylglycerin, Isopropyl
Alcohol, Phenoxyethanol, Triethanolamine.
_QUESTIONS?_
(310) 320-0100
o
o
RELABELED BY:
Enovachem PHARMACEUTICALS
Torrance, CA 90501
ZYLOTROL
lidocaine hcl 4%, menthol 1% gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:76420-145(NDC:81902-201)
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE -
UNII:98PI200987)
LIDOCAINE HYDROCHLORIDE
ANHYDROUS
4 g
in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL,
UNSPECIFIED FORM - UNII:L7T10EIP3A)
MENTHOL, UNSPECIFIED FORM
1 g
in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ETHYLHEXYLGLYCERIN (UNII: 147D
                                
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