COLD HOT PATCH- menthol patch 
Zhejiang Bangli Medical Products 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.

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cold& hot patch

Active Ingredient

Menthol 5.00%.

Purpose

Topical analgesic

Use

temporarily relieves minor aches and pains of muscles and joints due to
.arthritis .simple backache .strains . sprains
.bursitis .tendonitis . Bruises . Cramps

Warnning

For external use only.
When using this product.use only as directed . avoid contact with eyes and mucous membranes. do not apply to wounds or damaged skin.do not bandage tightly or use a heating pad
Stop use and ask doctor if
.excessive redness or irritation is present
.condition worsens
.pain persist for more than 7 days
.symptoms clear up and occur again within a few days
If pregnant or breast-feeding, ask a health professional before use, keep out of reach of childeren.If swallowed, get medical help or contact a poison control center right away.

keep out of reach of childeren.If swallowed, get medical help or contact a poison control center right away.

Directions

.adults and children 12 years and over: apply patch to affected area as needed but not more than 4 times daily
.children under 12 years: ask a doctor
. for easy application: grasp both ends of pad firmly, pull at both ends. Stretch pad until the backing separates.
Remove protective film while applying pad directly to site of pain.

Inactive Ingredients

Acrylic Acid,Aluminum Hydroxide,Carmellose Sodium,2 Ethylhexyl Acrylate,Glycerin,Isopropyl Myristate,Methyl Acrylate,Nonoxynol 30,
Polyacrylate,Polyacrylic Acid,Polysorbate 80,Sorbitan Sesquioleate,Starch,Talc,Tartaric Acid,Titanium Dioxide,Water

image description

COLD HOT PATCH 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57900-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Acrylic Acid (UNII: J94PBK7X8S)  
Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
Glycerin (UNII: PDC6A3C0OX)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Methyl Acrylate (UNII: WC487PR91H)  
NONOXYNOL-30 (UNII: JJX07DG188)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
STARCH, POTATO (UNII: 8I089SAH3T)  
Talc (UNII: 7SEV7J4R1U)  
Tartaric Acid (UNII: W4888I119H)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57900-002-014 in 1 CARTON
112 in 1 PACKAGE
11 in 1 BOX
12 in 1 BAG
10.408 g in 1 PATCH
2NDC:57900-002-023 in 1 CARTON
212 in 1 PACKAGE
26 in 1 BOX
21 in 1 BAG
20.408 g in 1 PATCH
3NDC:57900-002-034 in 1 CARTON
312 in 1 PACKAGE
31 in 1 BOX
33 in 1 BAG
30.408 g in 1 PATCH
4NDC:57900-002-0450 in 1 CARTON
41 in 1 BOX
45 in 1 BAG
40.408 g in 1 PATCH
5NDC:57900-002-0548 in 1 CARTON
53 in 1 BOX
51 in 1 BAG
50.408 g in 1 PATCH
6NDC:57900-002-068 in 1 CARTON
66 in 1 PACKAGE
61 in 1 BOX
65 in 1 BAG
60.408 g in 1 PATCH
7NDC:57900-002-074 in 1 CARTON
76 in 1 PACKAGE
71 in 1 BOX
75 in 1 BAG
70.408 g in 1 PATCH
8NDC:57900-002-084 in 1 CARTON
850 in 1 PACKAGE
81 in 1 BOX
85 in 1 BAG
80.85 g in 1 PATCH
9NDC:57900-002-0930 in 1 CARTON
91 in 1 BOX
95 in 1 BAG
90.595 g in 1 PATCH
10NDC:57900-002-108 in 1 CARTON
106 in 1 PACKAGE
101 in 1 BOX
105 in 1 BAG
100.595 g in 1 PATCH
11NDC:57900-002-114 in 1 CARTON
116 in 1 PACKAGE
111 in 1 BOX
115 in 1 BAG
110.595 g in 1 PATCH
12NDC:57900-002-128 in 1 CARTON
126 in 1 PACKAGE
121 in 1 BOX
123 in 1 BAG
121.487 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/18/2014
Labeler - Zhejiang Bangli Medical Products CO.,LTD (421295875)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Bangli Medical Products CO.,LTD421295875manufacture(57900-002)

Revised: 3/2014
Document Id: 9fc97756-8b39-4e37-85f1-bffdc6d3334c
Set id: 4c1dbeae-29fc-445d-bd7a-d2141f29fb76
Version: 1
Effective Time: 20140318
 
Zhejiang Bangli Medical Products CO.,LTD