MANGO BAY 0.5% LIDOCAINE GEL- lidocaine gel

Mango Bay 0.5% Lidocaine Gel by

Drug Labeling and Warnings

Mango Bay 0.5% Lidocaine Gel by is a Otc medication manufactured, distributed, or labeled by Inspec Solutions LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Lidocaine ............. 0.5%

PURPOSE

Lidocaine 0.5% ............. Pain Reliever

INDICATIONS & USAGE

Temporary relief of pain and itching due to

- sunburn - minor burn - insect bites - minor cuts - scraps

WARNINGS

Warnings

For external use only

When using this product keep out of eyes

Rinse with warter to remove

STOP USE

Sop use and ask a doctor

system persist for more than 7 days.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION

Direction

Adults and children 2 years and older: aooly to affected area not more that 3-4 times a day

Children under 2 years of age: consult a physician.

INACTIVE INGREDIENT

Inactive Ingredients: Aloe Barbadensis Leaf Extract, Carbomer, Diazolidinyl Urea, Disodium EDTA, Glycerin, Isopropyl Alcohol, Menthol, Polysorbate 80, Propylene Glycol, Triethanolamine, Water, Yellow 5.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MANGO BAY 0.5% LIDOCAINE GEL 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72667-042
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MENTHOL (UNII: L7T10EIP3A)
PROPYLENE GLYCOL 2-STEARATE (UNII: 5317AOR1RX)
TROLAMINE SALICYLATE (UNII: H8O4040BHD)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 1342 (UNII: 809Y72KV36)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
DISODIUM HEDTA (UNII: KME849MC7A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
FD&C YELLOW NO. 5 FREE ACID (UNII: 6TP696149N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72667-042-01	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/25/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/25/2022

Labeler - Inspec Solutions LLC. (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(72667-042)