ZENOL MILD HOT- methyl salicylate, vanillyl nonylamide patch

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

NONIVAMIDE (UNII: S846B891OR) (NONIVAMIDE - UNII:S846B891OR), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

זמין מ:

Lydia Co., Ltd.

מסלול נתינה (של תרופות):

TRANSDERMAL

סוג מרשם:

OTC DRUG

סממני תרפויטית:

For temporary relief of minor aches & pains of muscles & joints Associated with: • Arthritis •Simple backache •Strains •Bruises •Sprains Adults and children 12 years of age and over: •Clean and dry affected area •Remove patch from film •Apply to affected area not more than 3 to 4 times daily •Remove patch from the skin after at most 8-hour application Children under 12 years of age:

מצב אישור:

OTC monograph not final

מאפייני מוצר

ZENOL MILD HOT- METHYL SALICYLATE, VANILLYL NONYLAMIDE PATCH
LYDIA CO., LTD.
_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._
----------
DRUG FACTS
Methyl salicylate
Vanillyl N-nonylamide (NONIVAMIDE)
Kaolin,Zine Oxide,Titanium Oxide,Galatin,Glycerin,Liquid
Paraffin,Polybutene,Sodium
Polyacrylate,Rubber Latex,Purified Water
For temporary relief of minor aches & pains of muscles & joints
Associated with:
• Arthritis •Simple backache •Strains •Bruises •Sprains
keep out of reach of the children
Adults and children 12 years of age and over:
•Clean and dry affected area •Remove patch from film
•Apply to affected area not more than 3 to 4 times daily
•Remove patch from the skin after at most 8-hour application
Children under 12 years of age:
use only as directed
do not bandage tightly or use with a healing pad
avoid contact with the eyes and mucous membranes
do not apply to wounds or damaged skin
for external use only
ZENOL MILD HOT
methyl salicylate, vanillyl nonylamide patch
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:72988-0025
ROUTE OF ADMINISTRATION
TRANSDERMAL
Lydia Co., Ltd.
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
NONIVAMIDE (UNII: S846B891OR) (NONIVAMIDE - UNII:S846B891OR)
NONIVAMIDE
1.75 mg
in 14 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID -
UNII:O414PZ 4LPZ )
METHYL SALICYLATE
105 mg in 14 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
KAOLIN (UNII: 24H4NWX5CO)
GLYCERIN (UNII: PDC6A3C0OX)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:72988-
0025-1
14 g in 1 POUCH; Type 0: Not a Combination
Product
10/01/2021
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph not
final
part348
10/01/2021
LABELER -
Lydia Co., Ltd.