Label: FREDS HYDROCORTISONE WITH ALOE- hydrocortisone cream
- NDC Code(s): 55315-181-56
- Packager: FRED'S, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 27, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
-
Uses
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
- eczema
- psoriasis
- poison ivy, oak, sumac
- insect bites
- detergents
- jewelry
- cosmetics
- soaps
- seborrheic dermatitis
- temporarily relieves external anal and genital itching
- other uses of this product should be only under the advice and supervision of a doctor
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
-
Warnings
For external use only
Do not use
- in the genital area if you have a vaginal discharge. Consult a doctor.
- for the treatment of diaper rash. Consult a doctor.
When using this product
- avoid contact with eyes
- do not use more than directed unless told to do so by a doctor
- do not put directly into the rectum by using fingers or any mechanical device or applicator
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Directions
-
for itching of skin irritation, inflammation, and rashes:
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: ask a doctor
-
for external anal and genital itching, adults:
- when practical, clean the affected area with mild soap and warm water and rinse thoroughly
- gently dry by patting or blotting with toilet tissue or a soft cloth before applying
- apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: ask a doctor
-
for itching of skin irritation, inflammation, and rashes:
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
fred's
PharmacyNDC 55315-181-56
Compare to the
Active Ingredient in
Cortizone•10®*MAXIMUM STRENGTH
Hydrocortisone
Cream 1%
Antipruritic (Anti-Itch)
Itch and Rash Relief- Eczema & Psoriasis
- Seborrheic Dermatitis
- Insect Bites & Poison Ivy
- External Genital & Anal Itching
- Skin Irritation & Rashes
With Healing Aloe
NET WT 1 oz (28.4g)
-
INGREDIENTS AND APPEARANCE
FREDS HYDROCORTISONE WITH ALOE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-181 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 cetostearyl alcohol (UNII: 2DMT128M1S) sodium lauryl sulfate (UNII: 368GB5141J) sodium cetostearyl sulfate (UNII: 7ZBS06BH4B) citric acid monohydrate (UNII: 2968PHW8QP) glycerin (UNII: PDC6A3C0OX) glyceryl monostearate (UNII: 230OU9XXE4) methylparaben (UNII: A2I8C7HI9T) mineral oil (UNII: T5L8T28FGP) paraffin (UNII: I9O0E3H2ZE) propylparaben (UNII: Z8IX2SC1OH) water (UNII: 059QF0KO0R) stearyl alcohol (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55315-181-56 1 in 1 CARTON 11/15/2018 1 28.4 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 NOT FINAL part348 11/15/2018 Labeler - FRED'S, INC. (005866116)