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COATS ALOE by TYCHASIS CORPORATION

Medically reviewed on November 2, 2017

Dosage form: lotion
Ingredients: ALLANTOIN 0.5g in 100mL
Labeler: TYCHASIS CORPORATION
NDC Code: 70211-702

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 LOTION

Active Ingredient:

Allantoin 0.5%

Purpose:

Skin Protectant.

Warnings:

For external use only.

Do not get into eyes.

Stop use 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.

Uses:

Temporarily protects minor:

  • cuts
  • scapes
  • 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 center right away.

Directions:

Apply as needed.

Inactive Ingredients:

aloe barbanesis leaf juice, ethylhexyl palmitate, glycerin, methylgluceth-20, glyceryl stearate, C12-15 alkyl benzoate, water, cetyl alcohol, triethanolomine, stearic acid, ethylhexyl stearate, diethylhexyl adipate, retinyl palmitate, tocopheryl acetate, laureth-4, laureth-23, carbomer, diazolidinyl urea, methylparaben, propylparaben

Questions:

Toll free 888-650-0040

Package label COATS ALOE LOTION

COATS ALOE 
allantoin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70211-702
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (ALLANTOIN) ALLANTOIN0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ETHYLHEXYL PALMITATE 
METHYL GLUCETH-20 
ETHYLHEXYL STEARATE 
GLYCERYL STEARATE SE 
C12-15 ALKYL BENZOATE 
CETYL ALCOHOL 
STEARIC ACID 
DIETHYLHEXYL ADIPATE 
VITAMIN A PALMITATE 
TOCOPHEROL 
LAURETH-4 
LAURETH-23 
DIAZOLIDINYL UREA 
PROPYLPARABEN 
WATER 
BOROGLYCERIN 
METHYLPARABEN 
Product Characteristics
Colorwhite (may be slightly off white due to natural variations of aloe vera) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:70211-702-0259 mL in 1 BOTTLE, DISPENSING
2NDC:70211-702-08237 mL in 1 BOTTLE, DISPENSING
3NDC:70211-702-33976 mL in 1 BOTTLE, DISPENSING
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(70211-702)

 
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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