- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT:
- PURPOSE:
- USES:
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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
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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 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.
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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
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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)