Mango Bay Aloe Gel Lidocaine HCI 0.5%

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]

MANGO BAY 0.5% LIDOCAINE GEL- lidocaine gel 
Inspec Solutions LLC.

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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Mango Bay Aloe Gel Lidocaine HCI 0.5%

Active Ingredient

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

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

Temporary relief of pain and itching due to

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

Warnings

For external use only

When using this product keep out of eyes

Rinse with warter to remove

Sop use and ask a doctor

system persist for more than 7 days.

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

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

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 not final	part348	06/25/2022

Labeler - Inspec Solutions LLC. (081030372)

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

Revised: 6/2022

Document Id: e260fcb6-7303-75cf-e053-2a95a90a72f1

34390-5

Set id: e260fc65-4d3d-edb4-e053-2995a90a41c8

Version: 3

Effective Time: 20220626