HAUTUKI by CUSTICS Drug Facts

HAUTUKI by

Drug Labeling and Warnings

HAUTUKI by is a Otc medication manufactured, distributed, or labeled by CUSTICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAUTUKI- cholecalciferol (vitamin d3) patch 
CUSTICS

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

Capsicum annuum extract

Hydrogenated Dicyclopentadiene/Isopentene/Isoprene/Styrene Copolymer (and) Mineral Oil (and) Hydrogenated Styrene/Butadiene Copolymer, coffee seed extract, soil mineral, cordycepin

It delivers nutrients such as vitamins in the patch to the body.

keep out of reach of the children

Use 1 patch per day (* 4hours per day). Children 4yrs & up. i.e back of hand, forearm, around knee,
back of foot. Avoid using lotion or creams in area of application as it will hinder absorption. Patchs
are water resistant NOT waterproof.

Do not use on damaged, broken or irritated skin. Keep out of reach of children 18 years or younger.

for external use only

HAUTUKI 
cholecalciferol (vitamin d3) patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83463-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	0.2 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM LACTATE (UNII: 2URQ2N32W3)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PHYTONADIONE (UNII: A034SE7857)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83463-0001-1	30 in 1 PACKAGE	05/01/2023	05/02/2023
1		0.25 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2023	05/02/2023

Labeler - CUSTICS (695734126)

Registrant - CUSTICS (695734126)

Establishment
Name	Address	ID/FEI	Business Operations
CUSTICS		695734126	manufacture(83463-0001)

Revised: 5/2023

Document Id: fc027c2d-efbb-7145-e053-6394a90a89d9

34390-5

Set id: fb61f7e3-eb38-5d38-e053-6294a90a1095

Version: 3

Effective Time: 20230518