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Cool Comfort

Dosage form: swab
Ingredients: WITCH HAZEL 60g in 100g
Labeler: Naticura Inc
NDC Code: 71453-211

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Naticura Cool Comfort

Drug Facts

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


COOL COMFORT 
organic witch hazel swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71453-211
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (WITCH HAZEL) WITCH HAZEL60 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
GLYCERIN 
ALCOHOL 
JOJOBA OIL 
Packaging
#Item CodePackage Description
1NDC:71453-211-00100 PACKET in 1 PACKAGE
12.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34611/29/2017
Labeler - Naticura Inc (203502570)
Registrant - Naticura Inc (203502570)
Establishment
NameAddressID/FEIOperations
PREMIER CARE INDUSTRIES, INC858442403manufacture(71453-211)

Revised: 11/2017
 
Naticura Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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