Label: ZIMS ADVANCED CRACK CREME WITH HYDROCORTISONE- hydrocortisone cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 66902-228-03 - Packager: NATURAL ESSENTIALS, 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 March 27, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT:
- PURPOSE:
- USES:
-
WARNINGS:
For external use only.
- When using this product avoid contact with the 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
-
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 2 to 3 times daily.
- Children Under 2 Years of Age: Ask a doctor.
- For External Anal and Genital Itching, Adults:
- When practical, dean the affected area with mild soap and warm water and rinse thoroughly.
- Gently dry by patting or blotting with toilet tissue or a soft doth before applying.
- Apply to affected area not more than 2 to 3 times dally.
- Children Under 12 Years of Age: Ask a doctor.
- Store at 20-25 degrees C / 68-77 degrees F.
-
INACTIVE INGREDIENTS:
Water, Aloe Barbadensis Leaf Juice, SD Alcohol 3-C, Propylene Glycol, Cetearyl Alcohol, Isocetyl Stearate, Caprylic/Capric Triglyceride, Pimenta Acris (Bay) Leaf Oil, Isostearyl Palmitate, Cetyi Palmitate, Arnica Montana Flower Extract, Carbomer, Glyceryl Stearate, Ceteth-20, PEG-100 Stearate, Triethanolamine, Disodium EDTA, Methylparaben, Diazolidinyl Urea, lodopropynyl Butylcarbamate.
- Principal Display Panel - Tube Label
-
INGREDIENTS AND APPEARANCE
ZIMS ADVANCED CRACK CREME WITH HYDROCORTISONE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66902-228 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 L Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA (UNII: O80TY208ZW) BAY LEAF OIL (UNII: 5UMH0U3W0V) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETYL ALCOHOL (UNII: 936JST6JCN) WATER (UNII: 059QF0KO0R) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) EDETATE DISODIUM (UNII: 7FLD91C86K) ALCOHOL (UNII: 3K9958V90M) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) METHYLPARABEN (UNII: A2I8C7HI9T) PEG-100 STEARATE (UNII: YD01N1999R) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) STEARYL PALMITATE (UNII: 214W90O2XZ) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66902-228-03 1 in 1 TUBE 1 0.00085 L in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2014 Labeler - NATURAL ESSENTIALS, INC. (947484713) Establishment Name Address ID/FEI Business Operations NATURAL ESSENTIALS, INC. 947484713 MANUFACTURE(66902-228)
