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cold hot patch by Zhejiang Bangli Medical Products CO.,LTD

Dosage form: patch
Ingredients: Menthol 5g in 100g
Labeler: Zhejiang Bangli Medical Products CO.,LTD
NDC Code: 57900-002

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.

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

COLD HOT PATCH 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57900-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (MENTHOL) Menthol5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Acrylic Acid 
Aluminum Hydroxide 
CROSCARMELLOSE SODIUM 
2-ETHYLHEXYL ACRYLATE 
Glycerin 
Isopropyl Myristate 
Methyl Acrylate 
NONOXYNOL-30 
SODIUM POLYACRYLATE (8000 MW) 
POLYACRYLIC ACID (8000 MW) 
Polysorbate 80 
Sorbitan Sesquioleate 
STARCH, POTATO 
Talc 
Tartaric Acid 
Titanium Dioxide 
Water 
Packaging
#Item CodePackage Description
1NDC:57900-002-014 PACKAGE in 1 CARTON
112 BOX in 1 PACKAGE
11 BAG in 1 BOX
12 PATCH in 1 BAG
10.408 g in 1 PATCH
2NDC:57900-002-023 PACKAGE in 1 CARTON
212 BOX in 1 PACKAGE
26 BAG in 1 BOX
21 PATCH in 1 BAG
20.408 g in 1 PATCH
3NDC:57900-002-034 PACKAGE in 1 CARTON
312 BOX in 1 PACKAGE
31 BAG in 1 BOX
33 PATCH in 1 BAG
30.408 g in 1 PATCH
4NDC:57900-002-0450 BOX in 1 CARTON
41 BAG in 1 BOX
45 PATCH in 1 BAG
40.408 g in 1 PATCH
5NDC:57900-002-0548 BOX in 1 CARTON
53 BAG in 1 BOX
51 PATCH in 1 BAG
50.408 g in 1 PATCH
6NDC:57900-002-068 PACKAGE in 1 CARTON
66 BOX in 1 PACKAGE
61 BAG in 1 BOX
65 PATCH in 1 BAG
60.408 g in 1 PATCH
7NDC:57900-002-074 PACKAGE in 1 CARTON
76 BOX in 1 PACKAGE
71 BAG in 1 BOX
75 PATCH in 1 BAG
70.408 g in 1 PATCH
8NDC:57900-002-084 PACKAGE in 1 CARTON
850 BOX in 1 PACKAGE
81 BAG in 1 BOX
85 PATCH in 1 BAG
80.85 g in 1 PATCH
9NDC:57900-002-0930 BOX in 1 CARTON
91 BAG in 1 BOX
95 PATCH in 1 BAG
90.595 g in 1 PATCH
10NDC:57900-002-108 PACKAGE in 1 CARTON
106 BOX in 1 PACKAGE
101 BAG in 1 BOX
105 PATCH in 1 BAG
100.595 g in 1 PATCH
11NDC:57900-002-114 PACKAGE in 1 CARTON
116 BOX in 1 PACKAGE
111 BAG in 1 BOX
115 PATCH in 1 BAG
110.595 g in 1 PATCH
12NDC:57900-002-128 PACKAGE in 1 CARTON
126 BOX in 1 PACKAGE
121 BAG in 1 BOX
123 PATCH 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/FEIOperations
Zhejiang Bangli Medical Products CO.,LTD421295875manufacture(57900-002)

 
Zhejiang Bangli Medical Products CO.,LTD

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Medically reviewed on Mar 19, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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