COOL COMFORT- organic witch hazel swab

Cool Comfort by

Drug Labeling and Warnings

Cool Comfort by is a Otc medication manufactured, distributed, or labeled by Naticura Inc, PREMIER CARE INDUSTRIES, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Organic Witch hazel 60%

Purpose

Astringent

Uses

• helps relieve the local itching and discomfort associated with hemorrhoids
• aids in protecting irritated anorectal areas.
• temporary relieves burning and irritation.

Warnings

For external use only.

Keep out of reach of children

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

When using this product

• Do  not use more than directed unless told to do so by a doctor
• do not put directly into rectum by using fingers or any mechanical device or applicator
• Store at room temperature 59-86o​F (15-300C)

Directions

• adult: 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 hemorrhoidal treatments, and then discard
• Dispose of pad in trash after use.Do not flush
• children under 12 years of age: consult a doctor

Inactive Ingredients

Organic Aloe Vera gel, Organic Glycerin, Natural Grain Alcohol, Organic Jojoba, Organic essential oils of Lavender, Cypress, Geranium.

Principal Display Panel

NDC: 71453-211-00

Naticura

CoolComfort

Personal Medicated Cleanisng Pads

Cools, Soothes, Comforts

Hemorrhoidal Pads with Organic Witch Hazel and Aloe

Organic non-GMO Ingredients for your safety: Paraben Free and Chemical Free

100 Moist Soft Cloth Pads

INGREDIENTS AND APPEARANCE

COOL COMFORT 
organic witch hazel swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71453-211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	60 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
JOJOBA OIL (UNII: 724GKU717M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71453-211-00	100 in 1 PACKAGE	11/29/2017
1		2.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	11/29/2017

Labeler - Naticura Inc (203502570)

Registrant - Naticura Inc (203502570)

Establishment
Name	Address	ID/FEI	Business Operations
PREMIER CARE INDUSTRIES, INC		858442403	manufacture(71453-211)