Label: REXALL HEMORRHOIDAL COOLING- phenylephrine hydrochloride and witch hazel gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 55910-416-26 - Packager: Dolgencorp, 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 July 13, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
-
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
- do not put this product into the rectum by using fingers or any mechanical device or applicator
-
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 - 26 g Carton Label
-
INGREDIENTS AND APPEARANCE
REXALL HEMORRHOIDAL COOLING
phenylephrine hydrochloride and witch hazel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-416 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 0.25 g in 100 g WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 50 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-416-26 26 g in 1 TUBE; Type 0: Not a Combination Product 07/12/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 07/12/2017 Labeler - Dolgencorp, Inc. (068331990) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(55910-416)