Label: PREPARATION H COOLING GEL- phenylephrine hcl, witch hazel gel
- NDC Code(s): 0573-2840-10, 0573-2840-20
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 1, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purposes
- Uses
-
Warnings
For external use only
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure or depression.
-
Directions
- adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a 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
-
Questions or comments?
Call weekdays 9 AM to 5 PM EST at 1-800-99PrepHor 1-800-997-7374
Additional information
Do Not Use if tube seal under cap embossed with “H” is broken or missing.
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
For most recent product information, visit www.preparationh.com
Trademarks owned or licensed by GSK
©2021 GSK or licensor
Made In Canada
Do Not Use if tube seal under cap embossed with “H” is broken or missing.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREPARATION H COOLING GEL
phenylephrine hcl, witch hazel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-2840 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 g WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 500 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE DISODIUM (UNII: 7FLD91C86K) HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SULISOBENZONE (UNII: 1W6L629B4K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-2840-10 1 in 1 CARTON 01/01/2004 1 26 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0573-2840-20 1 in 1 CARTON 01/01/2004 2 51 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 Drug M015 01/01/2004 Labeler - Haleon US Holdings LLC (079944263) Establishment Name Address ID/FEI Business Operations Pf Soins De Santé Sri 203812479 manufacture(0573-2840)