GREEN GUARD TOPICAL PAIN RELIEF- lidocaine hci spray

GREEN GUARD Topical Pain Relief by

Drug Labeling and Warnings

GREEN GUARD Topical Pain Relief by is a Otc medication manufactured, distributed, or labeled by Ultra Distributors Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• in large quantities, particularly over raw or blistered areas
• near eyes, if this happens rinse thoroughly with water

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

• spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
• not to be used on Children under 12 years of age

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

SPL UNCLASSIFIED SECTION

Topical Pain Relief

Relieves pain of minor burns

Store at 68°-77°F (20°-25°C)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GREEN GUARD TOPICAL PAIN RELIEF 
lidocaine hci spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78495-132
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78495-132-01	59.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/19/2020

Labeler - Ultra Distributors Inc (007160073)