PAIN RELIEVING BURN GEL- burn gel gel 
Yuyao Jessie Commodity 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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51414-909 Pain Relieving Burn Gel

Active Ingredient

Lidocaine 2%

Purpose

pain reliever

Use

temporary relief from minor aches and pains of sore muscles &joints associated with arthritis ,backache,strains,sprains

WARNINGS

For External use only.

Flammable :keep away from excessive heat or open flame

ask a doctor before use if you have:senstive skin

when using this product :avoid contact with eyes and mucous membranes.do not apply to wounds or damaged skin.

do not use with other ointments.creams ,sprays or liniments .

do not apply to irrtated skin or if excessive irritation develops

do not bandage.

wash hands after use with cool water

do not use with heating pad or device.

if pregnant or breast-feeding;ask a health professional before use.

keep out of reach of children

if accidentally ingested,get dedical help or contact a Poison Control Center immediately.

Directions

Adults &Children over 2 years of age:rub a thin film over affected areas no more than 4 times a day-message not necessary.

Children under 2 years of age:consult physican

Inactive ingredients

Water,Menthol Propylene Glycol,Triethanolamine,Carbomer

lebel

2

PAIN RELIEVING BURN GEL 
burn gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51414-909
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TRIETHANOLAMINE DIOLEATE (UNII: 40Q022F4GX)  
CARBOMER 934 (UNII: Z135WT9208)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51414-909-010.5 g in 1 PACKAGE; Type 0: Not a Combination Product01/04/2019
2NDC:51414-909-020.9 g in 1 PACKAGE; Type 0: Not a Combination Product01/04/2019
3NDC:51414-909-032 g in 1 PACKAGE; Type 0: Not a Combination Product01/04/2019
4NDC:51414-909-042.5 g in 1 PACKAGE; Type 0: Not a Combination Product01/04/2019
5NDC:51414-909-053 g in 1 PACKAGE; Type 0: Not a Combination Product01/04/2019
6NDC:51414-909-063.5 g in 1 PACKAGE; Type 0: Not a Combination Product01/04/2019
7NDC:51414-909-074 g in 1 PACKAGE; Type 0: Not a Combination Product01/04/2019
8NDC:51414-909-084.5 g in 1 PACKAGE; Type 0: Not a Combination Product01/04/2019
9NDC:51414-909-095 g in 1 PACKAGE; Type 0: Not a Combination Product01/04/2019
10NDC:51414-909-105.5 g in 1 PACKAGE; Type 0: Not a Combination Product01/04/2019
11NDC:51414-909-116 g in 1 PACKAGE; Type 0: Not a Combination Product01/01/2019
12NDC:51414-909-126.5 g in 1 PACKAGE; Type 0: Not a Combination Product01/04/2019
13NDC:51414-909-137 g in 1 PACKAGE; Type 0: Not a Combination Product01/04/2019
14NDC:51414-909-1410 g in 1 BOTTLE; Type 0: Not a Combination Product01/04/2019
15NDC:51414-909-1515 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
16NDC:51414-909-1620 g in 1 BOTTLE; Type 0: Not a Combination Product01/04/2019
17NDC:51414-909-1730 g in 1 BOTTLE; Type 0: Not a Combination Product01/04/2019
18NDC:51414-909-1840 g in 1 BOTTLE; Type 0: Not a Combination Product01/04/2019
19NDC:51414-909-1950 g in 1 BOTTLE; Type 0: Not a Combination Product01/04/2019
20NDC:51414-909-2060 g in 1 BOTTLE; Type 0: Not a Combination Product01/04/2019
21NDC:51414-909-2190 g in 1 BOTTLE; Type 0: Not a Combination Product01/04/2019
22NDC:51414-909-22100 g in 1 BOTTLE; Type 0: Not a Combination Product01/04/2019
23NDC:51414-909-23120 g in 1 BOTTLE; Type 0: Not a Combination Product01/04/2019
24NDC:51414-909-24240 g in 1 BOTTLE; Type 0: Not a Combination Product01/04/2019
25NDC:51414-909-25300 g in 1 BOTTLE; Type 0: Not a Combination Product01/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/01/2019
Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)
Establishment
NameAddressID/FEIBusiness Operations
Yuyao Jessie Commodity Co.,Ltd.529892305manufacture(51414-909)

Revised: 3/2022
 
Yuyao Jessie Commodity Co.,Ltd.