GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE: Package Insert and Label Information

GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE- lidocaine hydrochloride and benzalkonium chloride cream
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.

Benzalkonium Chloride 0.13%
Lidocaine HCL 0.5%

Purpose

Purpose: First aid antiseptic, external analgesic

Use

First aid to help prevent infection and for the temporary relief of pain and itching associated with:

Minor Cuts

Scrapes

Burns

WARNINGS

keep out of reach of children

Keep out of reach of children.

If ingested,contact a poison control center right away.

Directions

Inactive ingredients

Peregal-O

Glycerin monostearate

Glycerol

Purified Water.

GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE benzalkonium chloride, lidocaine cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51414-904 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 0.5 g in 100 g BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 100 g

Inactive Ingredients Ingredient Name Strength POLYOXYL 20 CETOSTEARYL ETHER GLYCERIN WATER GLYCERYL ISOSTEARATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51414-904-01 0.5 g in 1 PACKET None 2 NDC:51414-904-02 0.9 g in 1 PACKET None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/20/2016

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

Establishment
Name	Address	ID/FEI	Operations
Yuyao Jessie Commodity Co.,Ltd.		529892305	manufacture (51414-904)

Revised: 01/2018 Yuyao Jessie Commodity Co.,Ltd.