REFUGE HC- hydrocortisone cream

Refuge HC by

Drug Labeling and Warnings

Refuge HC by is a Otc medication manufactured, distributed, or labeled by CoValence Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient(s):  Hydrocortisone 1%

PURPOSE

Purpose:  For itchy skin.

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.  Children under 12 years of age:  do not use, consult a physician.

INDICATIONS & USAGE

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

WARNINGS

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Prinicpal Display Panel

INGREDIENTS AND APPEARANCE

REFUGE HC 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66915-531
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	.01 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66915-531-01	30 g in 1 JAR
2	NDC: 66915-531-02	200000 g in 1 DRUM

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/02/2011

Labeler - CoValence Inc. (070659375)

Establishment
Name	Address	ID/FEI	Business Operations
CoValence Inc.		070659375	manufacture