GREEN GUARD TOPICAL PAIN RELIEF- lidocaine hci spray 
Ultra Distributors Inc

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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GREEN GUARD®
Burn spray

Active ingredient

Lidocaine HCI 2.0%

Purpose

Topical pain relief

Uses

Temporary pain relief associated with minor burns

Warnings

For external use only.

Do not use

Stop use and ask a doctor

if condition worsens or persists for more than 7 days or clears up and returns.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9,PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

Questions or comments?

1-800-869-6970

Topical Pain Relief

Relieves pain of minor burns

Store at 68°-77°F (20°-25°C)

image of bottle label

GREEN GUARD TOPICAL PAIN RELIEF 
lidocaine hci spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78495-132
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TEA TREE OIL (UNII: VIF565UC2G)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78495-132-0159.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/19/2020
Labeler - Ultra Distributors Inc (007160073)

Revised: 12/2020
Document Id: b6f10314-0e41-c0d4-e053-2a95a90a270a
Set id: b6f0041c-47fc-0bcd-e053-2a95a90ab1f9
Version: 1
Effective Time: 20201220
 
Ultra Distributors Inc