FIRST HONEY BURN SALVE- allantoin cream

First honey Burn Salve by

Drug Labeling and Warnings

First honey Burn Salve 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

When using product

• do not get into eyes

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

Do not use on

• Deep or puncture
• wounds
• Animal bites
• Serious burns

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

Aloe Barbadensis Leaf Juice, Anthemis Nobilis Flower Oil, Argania Spinosa Kernel Oil, Benzyl Alcohol, Caprylic/Capric Triglyceride, Cucumis Sativus Fruit Extract, Ethylhexylglycerin, Helianthus Annuus Extract, Lavandula Angustifolia Oil, Lecithin, Manuka Honey, Mixed Tocopherols, Oryza Sativa Bran Extract, Propanediol, Rosa Canina Seed Oil, Rosmarinus Officinalis Leaf Extract, Sodium Acrylates Copolymer, Soya Bean Oil, Tetrahexyldecyl Ascorbate, Tocopherol, Water (Aqua).

Questions or comments?

1-615-212-8585

Package Labeling:

Package Labeling: 81995-056-02

INGREDIENTS AND APPEARANCE

FIRST HONEY BURN SALVE 
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81995-056
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 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
ARGAN OIL (UNII: 4V59G5UW9X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAVENDER OIL (UNII: ZBP1YXW0H8)
HONEY (UNII: Y9H1V576FH)
TOCOPHEROL (UNII: R0ZB2556P8)
PROPANEDIOL (UNII: 5965N8W85T)
ROSA CANINA SEED OIL (UNII: MHT97MG5P8)
ROSEMARY (UNII: IJ67X351P9)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81995-056-01	1 in 1 CARTON	05/10/2022
1		100 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 81995-056-02	1 in 1 CARTON	06/01/2023
2		5 mL in 1 POUCH; 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	05/10/2022

Labeler - First Honey, LLC (080994597)