Label: 999 ITCH RELIEVING- hydrocortisone ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 69436-930-20 - Packager: Guangdong CR. Shunfeng Pharmaceutical Co 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 February 11, 2015
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- Purpose
- Use
- Warnings
- Stop use and seek medical advice if
- Directions
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
- Other Information
- Inactive Ingredients
- Drug Facts
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
999 ITCH RELIEVING
hydrocortisone ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69436-930 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 GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERYL DISTEARATE (UNII: 73071MW2KM) GLYCERIN (UNII: PDC6A3C0OX) STEARIC ACID (UNII: 4ELV7Z65AP) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) PARAFFIN (UNII: I9O0E3H2ZE) CERESIN (UNII: Q1LS2UJO3A) BETA CAROTENE (UNII: 01YAE03M7J) ETHYLPARABEN (UNII: 14255EXE39) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69436-930-20 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 07/20/1989 Labeler - Guangdong CR. Shunfeng Pharmaceutical Co Ltd (654033877) Registrant - Guangdong CR. Shunfeng Pharmaceutical Co Ltd (654033877) Establishment Name Address ID/FEI Business Operations Guangdong CR. Shunfeng Pharmaceutical Co Ltd 654033877 manufacture(69436-930)