Label: MAKESENSE- phenylephrine hydrochloride zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69020-205-28 - Packager: Cherry Hill Sales Co
- Category: HUMAN OTC DRUG LABEL
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 August 11, 2014
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
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Stop use and ask a doctor if
■ condition worsens or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days ■ Do not exceed the recomended daily dosage unless directed by a doctor ■ In case of bleeding, consult a doctor promptly ■ Certain persons can develop allergic reactions to ingredients in this product ■ If the symptom treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult doctor ■ If you are pregnant, do not use this product without first consulting doctor.
- Keep out of reach of children
- Directions
- Other information
- Inactive Ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
MAKESENSE
phenylephrine hydrochloride zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69020-205 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.25 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 12.5 g in 100 g Inactive Ingredients Ingredient Name Strength CERESIN (UNII: Q1LS2UJO3A) LANOLIN (UNII: 7EV65EAW6H) METHYLPARABEN (UNII: A2I8C7HI9T) PARAFFIN (UNII: I9O0E3H2ZE) PETROLATUM (UNII: 4T6H12BN9U) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69020-205-28 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 07/31/2014 Labeler - Cherry Hill Sales Co (145959768)