PAIN RELIEVING BURN GEL- burn gel gel

Pain Relieving Burn Gel by

Drug Labeling and Warnings

Pain Relieving Burn Gel by is a Otc medication manufactured, distributed, or labeled by Yuyao Jessie Commodity Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PAIN RELIEVING BURN GEL 
burn gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51414-909
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIETHANOLAMINE DIOLEATE (UNII: 40Q022F4GX)
CARBOMER 934 (UNII: Z135WT9208)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51414-909-01	0.5 g in 1 PACKAGE; Type 0: Not a Combination Product	01/04/2019
2	NDC: 51414-909-02	0.9 g in 1 PACKAGE; Type 0: Not a Combination Product	01/04/2019
3	NDC: 51414-909-03	2 g in 1 PACKAGE; Type 0: Not a Combination Product	01/04/2019
4	NDC: 51414-909-04	2.5 g in 1 PACKAGE; Type 0: Not a Combination Product	01/04/2019
5	NDC: 51414-909-05	3 g in 1 PACKAGE; Type 0: Not a Combination Product	01/04/2019
6	NDC: 51414-909-06	3.5 g in 1 PACKAGE; Type 0: Not a Combination Product	01/04/2019
7	NDC: 51414-909-07	4 g in 1 PACKAGE; Type 0: Not a Combination Product	01/04/2019
8	NDC: 51414-909-08	4.5 g in 1 PACKAGE; Type 0: Not a Combination Product	01/04/2019
9	NDC: 51414-909-09	5 g in 1 PACKAGE; Type 0: Not a Combination Product	01/04/2019
10	NDC: 51414-909-10	5.5 g in 1 PACKAGE; Type 0: Not a Combination Product	01/04/2019
11	NDC: 51414-909-11	6 g in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2019
12	NDC: 51414-909-12	6.5 g in 1 PACKAGE; Type 0: Not a Combination Product	01/04/2019
13	NDC: 51414-909-13	7 g in 1 PACKAGE; Type 0: Not a Combination Product	01/04/2019
14	NDC: 51414-909-14	10 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2019
15	NDC: 51414-909-15	15 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019
16	NDC: 51414-909-16	20 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2019
17	NDC: 51414-909-17	30 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2019
18	NDC: 51414-909-18	40 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2019
19	NDC: 51414-909-19	50 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2019
20	NDC: 51414-909-20	60 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2019
21	NDC: 51414-909-21	90 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2019
22	NDC: 51414-909-22	100 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2019
23	NDC: 51414-909-23	120 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2019
24	NDC: 51414-909-24	240 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2019
25	NDC: 51414-909-25	300 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	01/01/2019

Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)

Establishment
Name	Address	ID/FEI	Business Operations
Yuyao Jessie Commodity Co.,Ltd.		529892305	manufacture(51414-909)