Premier Value®

Premier Value®
SPL v2
SPL
SPL Set ID 05cb462d-6536-4445-a053-c45c9c52d317
Route
TOPICAL
Published
Effective Date 2019-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (0.0086 g)
Inactive Ingredients
Alcohol Citric Acid Monohydrate Diazolidinyl Urea Glycerin Methylparaben Propylene Glycol Propylparaben Sodium Citrate, Unspecified Form Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-12-10

Description

Witch Hazel, 50%

Purpose

Astringent


Medication Information

Warnings and Precautions

Warnings For external use only. Avoid contact with eyes.

When using this product • do not exceed the recommended daily dosage unless directed by a doctor. • do not put directly into rectum by using fingers or any mechanical device.

Stop use and ask a doctor if • Rectal bleeding occurs • Condition worsens or does not improve within 7 days

Indications and Usage

Use  Temporarily relieves these external symptoms associated with hemorrhoids:

• itching • burning • irritation

Purpose

Astringent

Dosage and Administration

Directions: As hemorrhoidal treatments for adults:

• When practical, clean the affected area with mild soap and warm water and rinse thoroughly.

• Gently dry by patting or blotting with toilet tissue or soft cloth before applying.

• Gently apply to the affected area by patting and then discard.

• Can be used up to six times daily or after each bowel movement

Children under 12 years of age: ask a doctor

Description

Witch Hazel, 50%

Section 42229-5

COMPARABLE TO TUCKS® MEDICATED PADS ACTIVE INGREDIENT*

Hemorrhoidal/Vaginal Pads with Witch Hazel

• Pre-moistened pads provide temporary relief of burning, itching and local discomfort associated with hemorrhoids

3.0 IN DIA (7.62 cm dia)

Other Uses For vaginal care - Cleanse the area by gently wiping, patting or blotting with pad and discard. Repeat as needed.

FOR YOUR PROTECTION, JAR IS SEALED. IF SEAL IS BROKEN OR MISSING, DO NOT USE.

Made in China

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue

Wayne, PA 19087

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Questions? Information?

Call Toll-Free (888) 401-5450

*This product is not manufactured or distributed by McNEIL-PPC, Inc, owner of the registered trademark TUCKS®

Section 44425-7

Other Information Store at 20° to 25°C (68° to 77°F)

Section 50565-1

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

Section 51727-6

Inactive Ingredients alcohol, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, sodium citrate, water

Packaging

Drug Facts

Active Ingredient

Witch Hazel, 50%


Structured Label Content

Indications and Usage (34067-9)

Use  Temporarily relieves these external symptoms associated with hemorrhoids:

• itching • burning • irritation

Dosage and Administration (34068-7)

Directions: As hemorrhoidal treatments for adults:

• When practical, clean the affected area with mild soap and warm water and rinse thoroughly.

• Gently dry by patting or blotting with toilet tissue or soft cloth before applying.

• Gently apply to the affected area by patting and then discard.

• Can be used up to six times daily or after each bowel movement

Children under 12 years of age: ask a doctor

Warnings and Precautions (34071-1)

Warnings For external use only. Avoid contact with eyes.

When using this product • do not exceed the recommended daily dosage unless directed by a doctor. • do not put directly into rectum by using fingers or any mechanical device.

Stop use and ask a doctor if • Rectal bleeding occurs • Condition worsens or does not improve within 7 days

Section 42229-5 (42229-5)

COMPARABLE TO TUCKS® MEDICATED PADS ACTIVE INGREDIENT*

Hemorrhoidal/Vaginal Pads with Witch Hazel

• Pre-moistened pads provide temporary relief of burning, itching and local discomfort associated with hemorrhoids

3.0 IN DIA (7.62 cm dia)

Other Uses For vaginal care - Cleanse the area by gently wiping, patting or blotting with pad and discard. Repeat as needed.

FOR YOUR PROTECTION, JAR IS SEALED. IF SEAL IS BROKEN OR MISSING, DO NOT USE.

Made in China

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue

Wayne, PA 19087

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Questions? Information?

Call Toll-Free (888) 401-5450

*This product is not manufactured or distributed by McNEIL-PPC, Inc, owner of the registered trademark TUCKS®

Section 44425-7 (44425-7)

Other Information Store at 20° to 25°C (68° to 77°F)

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive Ingredients alcohol, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, sodium citrate, water

Purpose

Astringent

Packaging

Drug Facts

Active Ingredient

Witch Hazel, 50%


Advanced Ingredient Data


Raw Label Data

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