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COATS ALOE by TYCHASIS CORPORATION

Medically reviewed on November 2, 2017

Dosage form: cream
Ingredients: ALLANTOIN 0.5mg in 100g
Labeler: TYCHASIS CORPORATION
NDC Code: 70211-703

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.

COATS ALOE CREME

Active Ingredient:

Allantoin 0.5%

Purpose:

Skin Protectant

Warnings:

For external use only.

Do not get into eyes.

Stop use and ask doctor if:

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.

Indications and Usage:

Temporarily protects minor:

  • cuts
  • scrapes
  • burns

Helps prevent and temporarily protects and helps relieve chaffed, chapped or cracked skin.

Helps prevent and protect from the drying effects of wind and cold weather.

Caution:

Do not use on deep puncture wounds, animal bites, serious burns.

Keep out of reach of children:

If swallowed, get medical help or contact a poison control right away.

Directions:

Apply as needed.

Inactive Ingredients:

water, aloe barbadenesis leaf juice, caprylic/capric triglyceride, cetyl alcohol, potassium palmityl hydrolyzed wheat protein, glyceryl stearate, pentylene glycol, butryospermum parkii (shea) butter, C12-15 alkyl benzoate, glycerin, beta-glucan, sodium hyaluronate, glyceryl stearate SE, ceteareth-20, dehydroacetic acid, benzyl alcohol

Questions:

Toll free number 888-650-0040

Package Label COATS ALOE CREME

COATS ALOE 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70211-703
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (ALLANTOIN) ALLANTOIN0.5 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ALOE VERA LEAF 
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE 
PENTYLENE GLYCOL 
SHEA BUTTER 
C12-15 ALKYL BENZOATE 
GLYCERIN 
HYALURONATE SODIUM 
POTASSIUM PALMITATE 
BENZYL ALCOHOL 
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) 
GLYCERYL STEARATE SE 
DEHYDROACETIC ACID 
Product Characteristics
Colorwhite (can be off-white due to natural variations of aloe vera) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:70211-703-04118 g in 1 JAR
2NDC:70211-703-16454 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/02/2015
Labeler - TYCHASIS CORPORATION (022731149)
Registrant - TYCHASIS CORPORATION (022731149)
Establishment
NameAddressID/FEIOperations
BIOMED LABORATORIES055329696manufacture(70211-703)

 
TYCHASIS CORPORATION

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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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