HEMORRHOIDAL SOOTHING WELL AT WALGREENS- phenylephrine hcl - .25% witch hazel extract - 50.0% spray
Walgreens

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.

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Drug Facts

Active ingredients Purpose

Phenylephrine HCl - .25% Vasoconstrictor
Witch Hazel Extract - 50.0% Astringent

Uses

Temporarily shinks hemorrhhoidal tissue. Temporarily reduces the swelling associated with irritation and other anorectal disorders.

Aids in protectiong irritated anorectal areas.

Warnings
For external use only.

Flammable: do not use while smoking or near heat

When using this product

avoid contact with eyes. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120oF

Ask a doctor or pharmacist before use if you have:

• heart disease • high blood pressure • thyroid disease • diabets • 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.

Stop use and ask a doctor if

• bleeding occurs • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days • needed for longer than 1 week

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

When practical, cleanse the affected area by patting or blotting with appropriate cleansing wipe. Spray rectal area until thoroughly moist. Wipe off excess with tissue. Gently dry by patting or blotting with a tissue or soft cloth. Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowl movement.

Children under 12 years of age: Consult a doctor

Inactive ingredients

Aloe Barbadensis Leaf Juice, Benzophenone-4, Disodium EDTA, Hydroxyethylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol,
Propylparaben, Sodium Citrate, Tocopheryl Acetate, Water

image description

HEMORRHOIDAL SOOTHING WELL AT WALGREENS
phenylephrine hcl - .25% witch hazel extract - 50.0% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-3206
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	25 g in 100 g
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	50 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SULISOBENZONE (UNII: 1W6L629B4K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)
Methylparaben (UNII: A2I8C7HI9T)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
Sodium Citrate (UNII: 1Q73Q2JULR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-3206-03	85 g in 1 CAN; Type 0: Not a Combination Product	04/15/2012	03/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	04/15/2012	03/01/2018

Labeler - Walgreens (008965063)

Registrant - Product Quest Mfg (927768135)

Name	Address	ID/FEI	Business Operations
Establishment
Product Quest Mfg		927768135	manufacture(0363-3206) , label(0363-3206)

Revised: 3/2018

Document Id: a64090ea-ec91-4b52-853e-72aea4e6d321

Set id: 8e2f3a6b-c062-4d1d-bc47-89e4ed117af9

Version: 2

Effective Time: 20180305

Walgreens