Label: PIYANPING ANTIITCH- hydrocortisone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68085-8012-4 - Packager: Guangdong Zhanjiang Jimin Pharmaceutical Company, Ltd.
- 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 January 30, 2012
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- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- DO NOT USE
- PURPOSE
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WARNINGS AND PRECAUTIONS
When using this product
• Avoid contact with eyes
• Do not begin use of any other hrdrocortisone product unless you have asked a doctor
• For external anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.
• Do not put this product into the rectum by using fingers or any mechanical device or applicator
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PIYANPING ANTIITCH
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68085-8012 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 camphor (synthetic) (UNII: 5TJD82A1ET) menthol (UNII: L7T10EIP3A) stearic acid (UNII: 4ELV7Z65AP) ethylparaben (UNII: 14255EXE39) glyceryl monostearate (UNII: 230OU9XXE4) glycerin (UNII: PDC6A3C0OX) mineral oil (UNII: T5L8T28FGP) trolamine (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68085-8012-4 1 in 1 BOX 1 20 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/16/2011 Labeler - Guangdong Zhanjiang Jimin Pharmaceutical Company, Ltd. (654041649) Registrant - Guangdong Zhanjiang Jimin Pharmaceutical Company, Ltd (654041649) Establishment Name Address ID/FEI Business Operations Guangdong Zhanjiang Jimin Pharmaceutical Company, Ltd 654041649 manufacture