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COATS ALOE by TYCHASIS CORPORATION

Dosage form: lotion
Ingredients: ALLANTOIN 0.5g in 100mL
Labeler: TYCHASIS CORPORATION
NDC Code: 58826-702

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 85%

Active Ingredient

Allantoin 0.5%

Purpose

Skin protectant

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 puncture wounds, animals bites, serious burns.

Uses

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.

Keep out of reach of children

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 barbadenesis leaf juice, ethylhexyl palmitate, glycerin, methyl gluceth-20, glyceryl stearate, C12-15 alkyl benzoate, water, cetyl alcohol, triethanolamine, stearice acid, ethylhexyl stearate, diethylhexyl adipate, retinyl palmitate, tocopheryl acetate, laureth-4, laureth-23, carbomer, diazolidinyl urea, methylparaben, propylparaben

COATS ALOE LOTION 8 OZ

Established Pharmacological Class
SubstancePharmacological Class
COATS ALOELotions, Oils, Powders, and Creams
COATS ALOE 
allantoin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58826-702
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (ALLANTOIN) ALLANTOIN0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYL PALMITATE 
ALOE VERA LEAF 
BOROGLYCERIN 
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 
METHYLPARABEN 
WATER 
PROPYLPARABEN 
Product Characteristics
Colorwhite (white lotion, can be off-white due to natural variation of aloe vera) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58826-702-08237 mL in 1 BOTTLE, DISPENSING
2NDC:58826-702-33976 mL in 1 BOTTLE, DISPENSING
3NDC:58826-702-0259 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/10/2015
Labeler - TYCHASIS CORPORATION (022731149)
Registrant - TYCHASIS CORPORATION (022731149)
Establishment
NameAddressID/FEIOperations
BIOMED LABORATORIES055329696manufacture(58826-702)

 
TYCHASIS CORPORATION

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Medically reviewed on Nov 9, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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