Label: BARMICIL ANTI-ITCH- hydrocortisone cream
- NDC Code(s): 69729-301-51
- Packager: OPMX LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 4, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
-
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.
-
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
- Inactive ingredient
- Purpose
- Content of labeling
-
INGREDIENTS AND APPEARANCE
BARMICIL ANTI-ITCH
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-301 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 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 Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-301-51 1 in 1 CARTON 02/10/2016 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 02/10/2016 Labeler - OPMX LLC (029918743) Registrant - Weeks & Leo (005290028) Establishment Name Address ID/FEI Business Operations Weeks & Leo Co., Inc. 005290028 manufacture(69729-301)
