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- 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.
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- 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 vagin*l 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
- 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 1g in100g 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)
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More Info on this Drug
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BARMICIL ANTI-ITCH- hydrocortisone cream
Number of versions: 6
Published Date (What is this?) | Version | Files |
---|---|---|
Dec 7, 2023 | 8 (current) | download |
Aug 10, 2023 | 7 | download |
Jun 13, 2022 | 6 | download |
Jun 1, 2022 | 5 | download |
Jan 24, 2022 | 4 | download |
Mar 28, 2019 | 3 | download |
RxNorm
BARMICIL ANTI-ITCH- hydrocortisone cream
RxCUI | RxNorm NAME | RxTTY | |
---|---|---|---|
1 | 106258 | hydrocortisone 1 % Topical Cream | PSN |
2 | 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD |
3 | 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY |
4 | 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY |
5 | 106258 | hydrocortisone 1 % Topical Cream | SY |
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NDC Codes
BARMICIL ANTI-ITCH- hydrocortisone cream
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
NDC | |
---|---|
1 | 69729-301-51 |