Premier Value®

Premier Value®
SPL v2
SPL
SPL Set ID 768c242d-6a2a-4419-aa70-7a481ba88f0d
Route
TOPICAL
Published
Effective Date 2019-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (0.02 g)
Inactive Ingredients
Alcohol Aloe Vera Leaf Citric Acid Monohydrate Diazolidinyl Urea Glycerin Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form

Identifiers & Packaging

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

Description

Witch hazel 50%

Purpose

Anorectal/Astringent


Medication Information

Purpose

Anorectal/Astringent

Description

Witch hazel 50%

Uses

• temporarily relieves the local itching and discomfort associated with hemorrhoids • aids in protecting irritated anorectal areas • temporarily relieves irritation and burning

Section 42229-5

COMPARABLE TO PREPARATION H ACTIVE INGREDIENT

Hemorrhoidal/Vaginal Wipes with Witch Hazel

Pre-moistened Cooling Wipes

Soothes & Comforts Irritated Areas

• 6 IN x 5 IN (15.2 cm x 12.7 cm)

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

Distributed By: Pharmacy Value Alliance, LLC • 407 East Lancaster Avenue, Wayne, Pa 19087

Other Uses:

For external vaginal care - cleanse the area by gently wiping, patting or blotting. Repeat as needed.

For use as a moist compress - if necessary, first cleanse the area. Fold new wipe to desired size and place in contact with irritated area for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed.

TAMPER EVIDENT: DO NOT USE IF POUCH IS OPEN OR DAMAGED.

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Preparation H® Medicated Wipes.

**Decolorized. Prop 65.

Made in China

Warnings

For external use only

When using this product

• do not use more than directed unless told to do so by a doctor

• do not put directly in the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• rectal bleeding occurs

• condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

Packaging

Directions

• open the lid on the top of the wipes pouch

• peel back wipes seal, remove completely and discard

• grab the top wipe at the edge of the center fold and pull out of pouch

• close lid after each use to retain moisture

• adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area

• use up to 6 times daily or after each bowel movement and before applying topical hemorroidal treatments, and then discard. Do Not Flush.

• children under 12 years of age: consult a doctor

Drug Facts

Active Ingredient

Witch hazel 50%

Other Information

• store at room temperature 20-25°C (68-77°F) • protect from excessive heat

Inactive Ingredients

alcohol, aloe vera leaf, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Keep Out of Reach of Children.

If swallowed get medical help or contact a Poison Control Centre (1-800-222-1222) right away.


Structured Label Content

Uses

• temporarily relieves the local itching and discomfort associated with hemorrhoids • aids in protecting irritated anorectal areas • temporarily relieves irritation and burning

Section 42229-5 (42229-5)

COMPARABLE TO PREPARATION H ACTIVE INGREDIENT

Hemorrhoidal/Vaginal Wipes with Witch Hazel

Pre-moistened Cooling Wipes

Soothes & Comforts Irritated Areas

• 6 IN x 5 IN (15.2 cm x 12.7 cm)

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

Distributed By: Pharmacy Value Alliance, LLC • 407 East Lancaster Avenue, Wayne, Pa 19087

Other Uses:

For external vaginal care - cleanse the area by gently wiping, patting or blotting. Repeat as needed.

For use as a moist compress - if necessary, first cleanse the area. Fold new wipe to desired size and place in contact with irritated area for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed.

TAMPER EVIDENT: DO NOT USE IF POUCH IS OPEN OR DAMAGED.

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Preparation H® Medicated Wipes.

**Decolorized. Prop 65.

Made in China

Purpose

Anorectal/Astringent

Warnings

For external use only

When using this product

• do not use more than directed unless told to do so by a doctor

• do not put directly in the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• rectal bleeding occurs

• condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

Packaging

Directions

• open the lid on the top of the wipes pouch

• peel back wipes seal, remove completely and discard

• grab the top wipe at the edge of the center fold and pull out of pouch

• close lid after each use to retain moisture

• adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area

• use up to 6 times daily or after each bowel movement and before applying topical hemorroidal treatments, and then discard. Do Not Flush.

• children under 12 years of age: consult a doctor

Drug Facts

Active Ingredient (Active ingredient)

Witch hazel 50%

Other Information (Other information)

• store at room temperature 20-25°C (68-77°F) • protect from excessive heat

Inactive Ingredients (Inactive ingredients)

alcohol, aloe vera leaf, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed get medical help or contact a Poison Control Centre (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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