BEARD MEDICATED CREMO- hydrocortisone cream

Beard Medicated Cremo by

Drug Labeling and Warnings

Beard Medicated Cremo by is a Otc medication manufactured, distributed, or labeled by Cremo company, Raining Rose, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Hydrocortisone 1% Anti-itch

PURPOSE

Uses

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

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.

INDICATIONS & USAGE

• Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days discontinue use and consult a doctor.

WARNINGS

Warnings

• For External use only
• When using this product avoid contact with eyes
• If contact occurs, rinse eyes thoroughly with water

DOSAGE & ADMINISTRATION

Directions

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

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

Cremo Beard Cream Medicated

Anti-itch formula

2 oz 56g

INGREDIENTS AND APPEARANCE

BEARD MEDICATED CREMO 
hydrocortisone cream

Product 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)