PREMIER VALUE MEDICATED PADS- witch hazel cloth

Premier Value Medicated Pads by

Drug Labeling and Warnings

Premier Value Medicated Pads by is a Otc medication manufactured, distributed, or labeled by Ashtel Studios, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Witch Hazel, 50%

Purpose

Astringent

INDICATIONS & USAGE

Use Temporarily relieves these external symptoms associated with hemorrhoids:

itching  burning  irritation

WARNINGS

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

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

DOSAGE & 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

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

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®

Packaging

INGREDIENTS AND APPEARANCE

PREMIER VALUE MEDICATED PADS 
witch hazel cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70108-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	0.0086 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70108-029-01	100 in 1 CASE; Type 0: Not a Combination Product	12/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	12/10/2019

Labeler - Ashtel Studios, Inc. (148689180)