BARMICIL ANTI-ITCH- hydrocortisone cream 
OPMX LLC

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Barmicil Hydrocortisone 1 oz

Active Ingredient

Hydrocortisone 1 %

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

eczema

seborrheic dermatitis

psoriasis

insect bites

poison ivy, poison oak, and poison sumac

cosmetics

jewelry

detergents

soaps

temporarily relieves external anal and genital itching

other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

When using this product

do not get into the eyes

for external anal itching, do not use more than directed unless told to do so by a doctor

do not put into the rectum by using fingers or any mechanical device or applicator

Do not use

for the treatment of diaper rash. Ask a doctor.

for external genital itching if you have a vaginal discharge. Ask a doctor.

for external anal itching if rectal bleeding occurs. Consult a doctor promptly.

Stop us and ask doctor if

condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

for external anal itching in adults:

when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, or by patting or blotting with an appropriate cleansing pad.

gently dry by patting or blotting with toilet tissue or a soft cloth before applying.

for external anal itching in children under 12 years: ask a doctor

Other information

store at 20 °C to 25 °C (68 °F to 77 °F)

Inactive ingredient

aloe barbadensis (aloe vera) leaf juice, cetearyl alcohol, glycerin, light mineral oil, potassium sorbate, purified water, sodium benzoate, sodium cetearyl sulfate, sodium lauryl sulfate, white petrolatum, white wax

Purpose

Anti-Itch

Content of labeling

Hydrocortisone Cream 1% with Aloe Vera Principal Display Panel

BARMICIL ANTI-ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-301
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
PETROLATUM (UNII: 4T6H12BN9U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
WHITE WAX (UNII: 7G1J5DA97F)  
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-301-511 in 1 CARTON02/10/2016
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/10/2016
Labeler - OPMX LLC (029918743)
Registrant - Weeks & Leo (005290028)
Establishment
NameAddressID/FEIBusiness Operations
Weeks & Leo Co., Inc.005290028manufacture(69729-301)

Revised: 12/2023
Document Id: 0bb887e1-9825-0191-e063-6294a90a6c82
Set id: 850084c3-1dd4-eb8d-e053-2a91aa0a130b
Version: 8
Effective Time: 20231204
 
OPMX LLC