ZIRO- hamamelis virginiana top water cream

ZIRO by

Drug Labeling and Warnings

ZIRO by is a Otc medication manufactured, distributed, or labeled by ZENMED Raging Creations Ltd., Sun Deep Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Witch Hazel Distillate(35%)

Purpose

Temporary Pain Reliever

Uses

For the temporary relief of anorectal discomfort associated with hemorrhoids.

Warnings

FOR EXTERNAL USE ONLY. If your condition does not improve after 7 days or bleeding occurs, consult a doctor. Do not exceed the recommended daily dosage unless directed by a doctor. Do not insert this product into the rectum using fingers or applicator. If pregnant or breast-feeding, consult a health professional before use. Children under 12 years of age, consult a doctor before use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

Directions

Apply externally to the affected area up to 6 times daily or after each bowel movement. Wash hands thoroughly before and after use.

Inactive Ingredients

Purified Water, Extracts of Sage, Coltsfoot, Yarrow, Balm Mint, Chamomile, Rosemary, Althea, Wild Thyme, & Horsetail. Vegetable Glycerin, Certified Organic Sunflower Oil & Aloe Vera Gel, Vitamins A, D3 & E, Soy Lecithin, Cocoa Butter, Stearic Acid, Octyl Palmitate, Allantoin, Benzyl Alcohol, Phenoxyethanol, Ethyl Hexyl Glycerin. 100% Vegan Ingredients.

PRINCIPAL DISPLAY PANEL - 60 ml Tube Label

ZIRO
Herbal Cream for
the Rapid Relief
of Hemorrhoids

+ Witch Hazel to Shrink &
Calm Inflamed Tissues

+ Based in All-Natural Cocoa
Butter to Soothe and Protect

+ Made with Certified
Organic Sunflower Oil &
Aloe Vera Gel

60 ml | 2 fl. oz
Made In The USA

INGREDIENTS AND APPEARANCE

ZIRO 
hamamelis virginiana top water cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83313-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) (HAMAMELIS VIRGINIANA TOP WATER - UNII:NT00Y05A2V)	HAMAMELIS VIRGINIANA TOP WATER	350 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SAGE (UNII: 065C5D077J)
TUSSILAGO FARFARA (UNII: 0JXZ63016V)
ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK)
CHAMOMILE (UNII: FGL3685T2X)
ROSEMARY (UNII: IJ67X351P9)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
WILD THYME (UNII: KXK6I80R8W)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
VITAMIN A (UNII: 81G40H8B0T)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
COCOA BUTTER (UNII: 512OYT1CRR)
STEARIC ACID (UNII: 4ELV7Z65AP)
OCTYL PALMITATE (UNII: UYY8LE6Q5Y)
ALLANTOIN (UNII: 344S277G0Z)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83313-0001-3	60 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M015	11/01/2023

Labeler - ZENMED Raging Creations Ltd. (203762150)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Deep Inc.		189788201	MANUFACTURE(83313-0001)