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ALOE PROPOLIS SOOTHING by Benton Inc.

Dosage form: gel
Ingredients: Allantoin 0.15g in 30mL
Labeler: Benton Inc.
NDC Code: 69998-170

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.

ACTIVE INGREDIENT

Active ingredient: Allantoin 0.50%

INACTIVE INGREDIENT

Inactive ingredients: Aloe Barbadensis Leaf Juice, Propolis Extract, Glycerin, Pentylene Glycol, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, Betaine, Arginine, Cucumis Sativus (Cucumber) Fruit Extract, Portulaca Oleracea Extract, Citrus Limon (Lemon) Fruit Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only. When using this product Do not get into eyes Stop use and ask a doctor if Condition worsens 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 poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses: Helps prevent and relieve chapped or cracked skin. Temporarily protects minor cuts, scrapes, burns.

Directions

Directions: Apply as needed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALOE PROPOLIS  SOOTHING
allantoin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69998-170
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (ALLANTOIN) Allantoin0.15 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin 
Pentylene Glycol 
Packaging
#Item CodePackage Description
1NDC:69998-170-021 TUBE in 1 CARTON
1NDC:69998-170-0130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/01/2016
Labeler - Benton Inc. (689852154)
Registrant - Benton Inc. (689852154)
Establishment
NameAddressID/FEIOperations
Benton Inc.689852154relabel(69998-170)
Establishment
NameAddressID/FEIOperations
EZEKIELCOSMETIC CO.,LTD689851966manufacture(69998-170)

Revised: 03/2017
 
Benton Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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