BEARD MEDICATED CREMO- hydrocortisone cream 
Cremo company

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.

----------

Cremo Medicated Beard Cream

Active Ingredients Purpose

Hydrocortisone 1% Anti-itch

Uses

For temporary relief of itching and minor skin irritation associated to eczema, soaps, detergents, and minor scrapes or scratches

Warnings

Directions

For adults: apply to affected area not more than 3 to 4 times daily.

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.

Cremo Beard Cream Medicated

Anti-itch formula

2 oz 56g

jar wrap

jar

BEARD MEDICATED CREMO 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71825-107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71825-107-0156 g in 1 JAR; Type 0: Not a Combination Product01/17/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/17/2019
Labeler - Cremo company (078708508)
Establishment
NameAddressID/FEIBusiness Operations
Raining Rose, Inc.083819404manufacture(71825-107)

Revised: 1/2019
Document Id: 7fab6f6f-7577-94ea-e053-2a91aa0a6e27
Set id: 7fab6f6f-7576-94ea-e053-2a91aa0a6e27
Version: 1
Effective Time: 20190117
 
Cremo company