Quality Choice medicated Pads

Quality Choice medicated Pads
SPL v2
SPL
SPL Set ID e8422db7-5e7e-4c9c-9142-1f042a0f22de
Route
TOPICAL
Published
Effective Date 2021-05-19
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 2021-05-12

Description

Witch Hazel, 50%

Purpose

Astringent


Medication Information

Purpose

Astringent

Description

Witch Hazel, 50%

Use

Temporarily relieves these external symptoms associated with hemorrhoids:

• itching   • burning   • irritation

Section 42229-5

* Compare to the Active Ingredient in TUCKS® Medicated pads

Hemorrhoidal/Vaginal pads with Witch Hazel

Pre-moistened Pads Provide Temporary Relief of Burning, Itching and Local Discomfort Associated with Hemorrhoids

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.

• SATISFACTION • GUARANTEED 100% QC

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Made in China

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

Section 50565-1

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

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

Packaging

Drug Facts

Directions:

As hemorrhoidal treatment 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

Active Ingredient

Witch Hazel, 50%

Other Information

Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

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


Structured Label Content

Use

Temporarily relieves these external symptoms associated with hemorrhoids:

• itching   • burning   • irritation

Section 42229-5 (42229-5)

* Compare to the Active Ingredient in TUCKS® Medicated pads

Hemorrhoidal/Vaginal pads with Witch Hazel

Pre-moistened Pads Provide Temporary Relief of Burning, Itching and Local Discomfort Associated with Hemorrhoids

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.

• SATISFACTION • GUARANTEED 100% QC

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Made in China

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

Section 50565-1 (50565-1)

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

Purpose

Astringent

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

Packaging

Drug Facts

Directions:

As hemorrhoidal treatment 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

Active Ingredient

Witch Hazel, 50%

Other Information

Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

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


Advanced Ingredient Data


Raw Label Data

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