Label: SELECT BRAND HEMORRHOID- glycerin, petrolatum, phenylephrine hydrochloride, pramoxine hydrochloride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 15127-590-00 - Packager: L&R Distributors, Inc.
- 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 January 24, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purposes
- Uses
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Warnings
For external use only
Ask a doctor before use if you have
- heart disease
- high blood pressure
- diabetes
- thyroid disease
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression
When using this product
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put this product into the rectum by using fingers or any mechanical device or applicator
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Directions
- Adults: when practical, cleanse and gently dry the affected area by patting or blotting with an appropriate cleansing tissue or soft cloth before applying
- when first opening the tube, puncture foil seal with top end of cap
- apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
- Children under 12 years of age: ask a doctor
- Other information
- Inactive ingredients
- Principal Display Panel - 1oz Carton Label
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INGREDIENTS AND APPEARANCE
SELECT BRAND HEMORRHOID
glycerin, petrolatum, phenylephrine hydrochloride, pramoxine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15127-590 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin 144 mg in 1 g Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum 150 mg in 1 g Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 2.5 mg in 1 g Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride 10 mg in 1 g Inactive Ingredients Ingredient Name Strength Aloe Vera Leaf (UNII: ZY81Z83H0X) 10 mg in 1 g Cetostearyl Alcohol (UNII: 2DMT128M1S) 10 mg in 1 g Cetyl Alcohol (UNII: 936JST6JCN) 20 mg in 1 g Glyceryl Monostearate (UNII: 230OU9XXE4) 22 mg in 1 g Mineral Oil (UNII: T5L8T28FGP) 69 mg in 1 g Peg-40 Castor Oil (UNII: 4ERD2076EF) 10 mg in 1 g Water (UNII: 059QF0KO0R) 500.5 mg in 1 g Propylene Glycol (UNII: 6DC9Q167V3) 20 mg in 1 g Stearyl Alcohol (UNII: 2KR89I4H1Y) 20 mg in 1 g .ALPHA.-Tocopherol Acetate (UNII: 9E8X80D2L0) 10 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:15127-590-00 1 in 1 CARTON 03/01/2014 1 28 g in 1 TUBE; 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 03/01/2014 Labeler - L&R Distributors, Inc. (012578514) Establishment Name Address ID/FEI Business Operations Natural Essentials 947484713 MANUFACTURE(15127-590)
