REFUGE HC - hydrocortisone cream 
CoValence Inc.

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.

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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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE.01 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)  
LEVOMENOL (UNII: 24WE03BX2T)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
SQUALANE (UNII: GW89575KF9)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
SOYBEAN OIL (UNII: 241ATL177A)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PHYTIC ACID (UNII: 7IGF0S7R8I)  
CARBOMER 934 (UNII: Z135WT9208)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
CoValence Inc.070659375manufacture

Revised: 8/2011
Document Id: 77a8eb20-9461-43ac-872e-11c3259a2167
Set id: 5bcdd479-b645-4209-9413-643dfa405c0f
Version: 2
Effective Time: 20110818
 
CoValence Inc.