Label: LEADER- phenylephrine hydrochloride and witch hazel cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49781-091-01 - Packager: Cardinal Health
- 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
- PURPOSE
- 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
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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 gel
- 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 - Carton Label
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INGREDIENTS AND APPEARANCE
LEADER
phenylephrine hydrochloride and witch hazel creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49781-091 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) phenylephrine hydrochloride 2.5 mg in 1 L witch hazel (UNII: 101I4J0U34) (witch hazel - UNII:101I4J0U34) witch hazel 500 mg in 1 L Inactive Ingredients Ingredient Name Strength aloe vera leaf (UNII: ZY81Z83H0X) edetate disodium (UNII: 7FLD91C86K) hydroxyethyl cellulose (100 mpa.s at 2%) (UNII: R33S7TK2EP) methylparaben (UNII: A2I8C7HI9T) polysorbate 80 (UNII: 6OZP39ZG8H) propylene glycol (UNII: 6DC9Q167V3) propylparaben (UNII: Z8IX2SC1OH) water (UNII: 059QF0KO0R) sodium citrate (UNII: 1Q73Q2JULR) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49781-091-01 1 in 1 CARTON 04/28/2014 1 0.026 L 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 04/28/2014 Labeler - Cardinal Health (097537435) Establishment Name Address ID/FEI Business Operations Natural Essentials 947484713 MANUFACTURE(49781-091)