ZYLOTROL MAXIMUM PAIN PATCH- lidocaine 4%, menthol 1% patch

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

ASCLEMED USA INC.

Administreringsrute:

TOPICAL

Resept typen:

OTC DRUG

Indikasjoner:

Topical Analgesic - in large quantities, particularly over raw surfaces, or blistered areas. For the temporary relief of pain.

Autorisasjon status:

OTC monograph not final

Preparatomtale

ZYLOTROL MAXIMUM PAIN PATCH- LIDOCAINE 4%, MENTHOL 1% PATCH
ASCLEMED USA INC.
----------
ZYLOTROL FOR PAIN CONTROL LIDOCAINE 4% AND MENTHOL 1%
Lidocaine 4%
Menthol 1%
Topical Analgesic
FOR EXTERNAL USE ONLY not intended for ingestion.
in large quantities, particularly over raw surfaces, or blistered
areas.
Avoid contact with eyes.
condition worsens, or if symtoms persist for more than 7 days or clear
up and occur
again within a few days.
If swallowed, get medical help, or contact a Poison Control Central
right away.
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.
Store at 20-25oC (68-77oF) and protect from moisture.
polyacrylamide, vinol, sodium polyacrylate; acrylate polymerization;
purified water.
QUESTIONS?
[phone]
USES
For the temporary relief of pain.
ZYLOTROL MAXIMUM PAIN PATCH
lidocaine 4%, menthol 1% patch
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:76420-144(NDC:81902-101)
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
LIDOCAINE
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
WATER (UNII: 059QF0KO0R)
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
ETHENYL (UNII: PQ2K3G3591)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:76420-144-
15
15 in 1 BOX
08/20/2021
1
4 g in 1 PATCH; Type 0: Not a Combination
Product
ASCLEMED USA INC.
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
505G(a)(3)
07/30/2021
LABELER -
ASCLEMED USA INC. (059888437)
ESTABLIS