Label: PSORMEDICOR PREMIUM SKIN CARE PRODUCT- coal tar ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 54095-111-10 - Packager: Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 November 11, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient:
- Purpose:
- Uses:
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Warnings:
For external use only. Will stain clothing. Avoid exposure to sun during treatment and for the following 24 hours.
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Directions:
- Read all package directions and warnings before using.
- Use as directed.
- Apply (gently massage in) a small amount of PsorMedicor to affected areas.
- Apply on clean skin or after a shower.
- Wait for 10 minutes to allow for ventilation, cover with single-use cloth.
- Leave on for at least 3 hours or during a night.
- Wash skin after treatment.
- Use for 7-14 days.
- Intended for use by normally healthy adults only.
- Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
- Questions or Comments?
- Inactive Ingredients:
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
PSORMEDICOR PREMIUM SKIN CARE PRODUCT
coal tar ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54095-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PETROLATUM (UNII: 4T6H12BN9U) COCOA BUTTER (UNII: 512OYT1CRR) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) OLIVE OIL (UNII: 6UYK2W1W1E) LANOLIN (UNII: 7EV65EAW6H) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) TROLAMINE (UNII: 9O3K93S3TK) THYMOL (UNII: 3J50XA376E) 1,3-DIMETHYLUREA (UNII: WAM6DR9I4X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54095-111-10 50 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 11/11/2013 Labeler - Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD (533464103)