Label: BEARD MEDICATED CREMO- hydrocortisone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71825-107-01 - Packager: Cremo company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated January 17, 2019
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients Water, Ethylhexyl Palmitate, Cetyl Alcohol, Glycerin, Butylene Glycol, Glyceryl Stearate, Stearic Acid, Coconut Oil, Cocoa Butter, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Cetearyl Alcohol, Polysorbate 60, Carbomer, Aminomethyl Propanol, Disodium EDTA, Allantoin, Vitamin E Acetate, Aloe Vera Leaf Extract, Organic Tea Tree Leaf Oil, Lavender Oil, Peppermint Oil, Organic Chamomile Blue (German) Flower Oil.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BEARD MEDICATED CREMO
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71825-107 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ALOE VERA LEAF (UNII: ZY81Z83H0X) TEA TREE OIL (UNII: VIF565UC2G) PEPPERMINT OIL (UNII: AV092KU4JH) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) COCOA BUTTER (UNII: 512OYT1CRR) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) ETHYLHEXYL PALMITATE (UNII: 2865993309) COCONUT OIL (UNII: Q9L0O73W7L) POLYSORBATE 60 (UNII: CAL22UVI4M) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) ALLANTOIN (UNII: 344S277G0Z) LAVENDER OIL (UNII: ZBP1YXW0H8) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71825-107-01 56 g in 1 JAR; Type 0: Not a Combination Product 01/17/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/17/2019 Labeler - Cremo company (078708508) Establishment Name Address ID/FEI Business Operations Raining Rose, Inc. 083819404 manufacture(71825-107)