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

Purpose

Anorectal/Astringent

Description

Witch hazel 50%


Medication Information

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

Uses

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

Purpose

Anorectal/Astringent

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

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

Description

Witch hazel 50%

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

Packaging

Drug Facts

Active Ingredient

Witch hazel 50%

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

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

Uses

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

Purpose

Anorectal/Astringent

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

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

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

Packaging

Drug Facts

Active Ingredient (Active ingredient)

Witch hazel 50%

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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