TN DICKINSONS MEDICATED COOLING FOAM HEMORRHOIDAL RELIEF- witch hazel liquid

TN Dickinsons Medicated Cooling Foam Hemorrhoidal Relief by

Drug Labeling and Warnings

TN Dickinsons Medicated Cooling Foam Hemorrhoidal Relief by is a Otc medication manufactured, distributed, or labeled by Dickinson Brands Inc., American Distilling Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

All natural distilled witch hazel 50% (including natural grain alcohol)

Purpose

Astringent

Uses

• helps relieve local burning, itching and discomfort associated with hemorrhoids and perineal area
• aids in the protection of irritated or inflamed anorectal areas

Warnings

For external use only

When using this product

• do not exceed recommended dosage unless recommended by a physician
• do not put this product into rectum by using fingers or any mechanical device or applicator

Stop use and ask doctor if

• condition worsens or does not improve within 7 days
• bleeding occurs

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

Directions

• adults: when practical, cleanse the affected area with mild soap & warm water and rinse thoroughly
• gently dry by blotting with toilet tissue or soft cloth before application
• pump once onto toilet paper & if desired, fold to deflate foam. Apply to affected area by patting then flush.
• postpartum, add foam on top of each maxi pad for healing relief.
• use up to 6 times daily or after each bowel movement
• children under 12 years of age: consult a doctor

Other information

• pack foam in hospital bag for instant relief post-delivery and place in bathroom for at home recovery.
• store at room temperature or in fridge for extra cooling.

Inactive ingredients

aloe barbadensis leaf juice, coco glucoside, glycerin, lactic acid, propanediol, purified water, sodium benzoate

QUESTIONS OR COMMENTS?

TNDickinsons.com
18888602279

SPL UNCLASSIFIED SECTION

Dist. by: Dickinson Brands Inc.
East Hampton, CT 06424

PRINCIPAL DISPLAY PANEL - 147 mL Bottle Label

#1 PHYSICIAN RECOMMENDED*
WITCH HAZEL BRAND

T.N.
DICKINSON'S®

Witch
hazel®

NEW
Medicated Cooling Foam

HEMORRHOIDAL RELIEF

Immediately Soothes
Inflamed, burning, itching
Hemorrhoidal, Vaginal &
Postpartum Perineal areas

MADE WITH
100% NATURAL
WITCH HAZEL

HEMORRHOIDAL WIPE ALTERNATIVE

5 FL. OZ. (147 mL) = Approx. 185 Wipes or Pads

Learn More!

INGREDIENTS AND APPEARANCE

TN DICKINSONS MEDICATED COOLING FOAM HEMORRHOIDAL RELIEF 
witch hazel liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52651-057
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	0.4 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
COCO-GLUCOSIDE (UNII: ICS790225B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52651-057-02	147 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/15/2025
2	NDC: 52651-057-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M015	03/15/2025

Labeler - Dickinson Brands Inc. (124620340)

Registrant - American Distilling Inc. (065524738)

Establishment
Name	Address	ID/FEI	Business Operations
American Distilling Inc.		065524738	MANUFACTURE(52651-057) , API MANUFACTURE(52651-057)