Label: SUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH- hydrocortisone cream
- NDC Code(s): 49348-521-72, 49348-521-78
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
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 25, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
-
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, oak, sumac
- soaps
- detergents
- cosmetics
- jewelry
- external genital and anal itching.
other uses of this product should be only under the advice and supervision of a doctor.
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Warnings
- for external use only
- avoid contact with the eyes
Stop using this product 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
- before you begin using any other hydrocortisone product
Do not use this product and ask a doctor
- if you have a vaginal discharge
- before treating diaper rash
- before using on children under 2 years of age
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
-
INGREDIENTS AND APPEARANCE
SUNMARK HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-521 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 aloe vera leaf (UNII: ZY81Z83H0X) cetostearyl alcohol (UNII: 2DMT128M1S) 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) sodium cetostearyl sulfate (UNII: 7ZBS06BH4B) sodium lauryl sulfate (UNII: 368GB5141J) stearyl alcohol (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-521-72 1 in 1 CARTON 05/01/2014 1 28.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49348-521-78 1 in 1 CARTON 05/21/2014 2 60 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 08/23/1995 Labeler - Strategic Sourcing Services LLC (116956644) Registrant - Taro Phamaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Phamaceuticals Inc. 206263295 MANUFACTURE(49348-521)