MANUKA HONEY EXTRA STRENGTH- allantoin gel

Manuka Honey Extra Strength by

Drug Labeling and Warnings

Manuka Honey Extra Strength by is a Otc medication manufactured, distributed, or labeled by First Honey LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Allantoin 0.5%

Purpose

Skin Protectant

Uses

• Temporarily protects minor
• cuts
• scrapes
• burns
• helps prevent and temporarily protects and helps relieve chafed, chapped, or cracked skin

Warnings

For external use only

Do not use

• In the eyes
• On deep or puncture wounds
• Animal bites
• Serious burns

Stop use and ask a doctor if

• Conditions worsen
• Symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

Apply as needed.

Inactive ingredients

Helianthus Annuus Extract, Lecithin, Mãnuka Honey, Oryza Sativa Bran Extract, Propanediol, Potassium Sorbate, Rosmarinus Officinalis Leaf Extract, Sodium Acrylates Copolymer, Sodium Benzoate, Tetrasodium Glutamate Diacetate, Tocopherol, Water (Aqua).

Questions?

1-615-488-8168

Package Labeling:

INGREDIENTS AND APPEARANCE

MANUKA HONEY EXTRA STRENGTH 
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81995-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPANEDIOL (UNII: 5965N8W85T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ROSEMARY (UNII: IJ67X351P9)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81995-050-01	1 in 1 CARTON	09/01/2024
1		21 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	09/01/2024

Labeler - First Honey LLC (080994597)