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glo SKIN BEAUTY Remedy Gel

Medically reviewed on December 28, 2017

Dosage form: gel
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: Hayden Caleel LLC
NDC Code: 60541-1900

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.

DRUG FACTS

Active Ingredients

Hydrocortisone 1%

Purpose

Anti-itch

Uses
  • temporarily relieves itching associate with minor skin irritations, inflammation an rashes due to:
  • dermatitis, exzema, insect bites
  • other uses of this prouct should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

  • for the treatment of iaper rash. Ask a doctor

When using this product
• avoid contact with the eyes
• do not use more than directed unless told to do so by a doctor

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hyrdrocortisone product unless you have asked a doctor

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
  • for itching of skin irritation, inflamation and rashes
  • adults an chilren 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use, ask a doctor

Inactive Ingredients

Aqua (Water), Glycerin, Caprylic/Capric Triglyceride, Cetearyl Olivate, Rosa Canina (Rose Hip) Fruit Oil, Squalane, Sorbitan Olivate, Bisabolol, Carbomer, Gluconolactone, Lonicera Caprifolium (Honeysuckle) Flower Extract, Hedychium Coronarium (White Ginger) Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Sodium Benzoate, Phenethyl Alcohol, Potassium Sorbate, Caprylyl Glycol, Tocopherol, Glycine Soja (Soybean) Oil, Aloe Barbadensis Leaf Juice Powder, Phytic Acid, Sodium Hydroxide, Xanthan Gum, Trisodium Ethylenediamine Disuccinate

Principal Display Panel

GLO SKIN BEAUTY REMEDY GEL 
glo skin beauty remedy gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60541-1900
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
CAPRYLIC/CAPRIC ACID 
ROSA CANINA FRUIT OIL 
SQUALANE 
SORBITAN OLIVATE 
.ALPHA.-BISABOLOL, (+)- 
CARBOMER 940 
GLUCONOLACTONE 
LONICERA CAPRIFOLIUM FLOWER 
HEDYCHIUM CORONARIUM ROOT 
LONICERA JAPONICA FLOWER 
SODIUM BENZOATE 
POTASSIUM SORBATE 
CAPRYLYL GLYCOL 
TOCOPHEROL 
SOYBEAN OIL 
ALOE VERA WHOLE 
SODIUM HYDRIDE 
XANTHAN GUM 
TRISODIUM ETHYLENEDIAMINE DISUCCINATE 
Packaging
#Item CodePackage Description
1NDC:60541-1900-31 BOTTLE in 1 CARTON
130 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/31/2017
Labeler - Hayden Caleel LLC (011367468)
Registrant - Hayden Caleel LLC (011367468)
Establishment
NameAddressID/FEIOperations
Island Kinetics, Inc. d.b.a. CoValence Laboratories959735002manufacture(60541-1900)

 
Hayden Caleel LLC

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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