Refuge HC

Dosage form: cream
Ingredients: HYDROCORTISONE .01mg in 1g
Labeler: CoValence Inc.
NDC Code: 66915-531

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 Ingredient(s):  Hydrocortisone 1%

Purpose:  For itchy skin.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.  Children under 12 years of age:  do not use, consult a physician.

Use:  For temporary relief of itching and discomfort associated with minor skin irritations, inflammation and rashes.

Warnings:  For external use only.  Avoid contact with eyes.

Directions:  Adults and children 12 years of age or older:  Apply to the affected area no more than 3 to 4 times daily.

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

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REFUGE HC 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66915-531
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE.01 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
MEDIUM-CHAIN TRIGLYCERIDES 
CETEARYL OLIVATE 
HEDYCHIUM CORONARIUM ROOT 
LEVOMENOL 
ROSA CANINA FRUIT OIL 
SQUALANE 
TOCOPHEROL 
ALOE VERA LEAF 
LONICERA CAPRIFOLIUM FLOWER 
LONICERA JAPONICA FLOWER 
SOYBEAN OIL 
SORBITAN OLIVATE 
XANTHAN GUM 
PHYTIC ACID 
CARBOMER 934 
POTASSIUM SORBATE 
SODIUM HYDROXIDE 
GLUCONOLACTONE 
SODIUM BENZOATE 
CAPRYLYL GLYCOL 
PHENYLETHYL ALCOHOL 
TRISODIUM ETHYLENEDIAMINE DISUCCINATE 
Packaging
#Item CodePackage Description
1NDC:66915-531-0130 g in 1 JAR
2NDC:66915-531-02200000 g in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/02/2011
Labeler - CoValence Inc. (070659375)
Establishment
NameAddressID/FEIOperations
CoValence Inc.070659375manufacture

Revised: 08/2011
 
CoValence Inc.

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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