Label: PRAMOXINE HYDROCHLORIDE aerosol, foam
- NDC Code(s): 51862-180-15
- Packager: Mayne Pharma
- 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.
Updated November 29, 2017
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- ACTIVE INGREDIENT:
- INACTIVE INGREDIENTS:
- DIRECTIONS: SHAKE WELL BEFORE USE.
Do not exceed the recommended daily dosage unless directed by a physician. If condition worsens or does not improve within 7 days, consult a physician. In case of rectal bleeding, consult a physician promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use immediately and consult a physician. Do not use in the eyes or nose. Do not apply to large areas of the body.
- CAUTION: FOR EXTERNAL USE ONLY.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 g Container Carton
INGREDIENTS AND APPEARANCE
pramoxine hydrochloride aerosol, foam
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51862-180 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) YELLOW WAX (UNII: 2ZA36H0S2V) METHYLPARABEN (UNII: A2I8C7HI9T) CETETH-20 (UNII: I835H2IHHX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SORBITAN TRIOLEATE (UNII: QE6F49RPJ1) TROLAMINE (UNII: 9O3K93S3TK) TETRAFLUOROMETHANE (UNII: 94WG9QG0JN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51862-180-15 1 in 1 CARTON 10/31/2011 1 15 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 10/31/2011 Labeler - Mayne Pharma (867220261) Establishment Name Address ID/FEI Business Operations Sciarra Laboratories, Inc. 824900369 MANUFACTURE(51862-180) , PACK(51862-180) , LABEL(51862-180)