Astral Organica Hand Sanitizer with CBD by Kabana Skin Care

Astral Organica Hand Sanitizer with CBD by

Drug Labeling and Warnings

Astral Organica Hand Sanitizer with CBD by is a Otc medication manufactured, distributed, or labeled by Kabana Skin Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ASTRAL ORGANICA HAND SANITIZER WITH CBD- hand sanitizer gel 
Kabana Skin Care

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.

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DRUG FACTS

Package Insert, not enough space on label for Drug Facts panel.

Astral Organica Hand Santizer + CBD package label - note QR code referencing Drug Facts that is easily accessible via smart devices.

ACTIVE INGREDIENT

ETHYL ALCOHOL 70% V/V

PURPOSE

ANTIMICROBIAL

DISCONTINUE USE IF IRRITATION OR REDNESS DEVELOPS.

IF CONDITION PERSISTS FOR MORE THAN 72 HOURS, CONSULT A DOCTOR.

WHEN USING THIS PRODUCT, DO NOT USE IN OR NEAR THE EYES. IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CENTER RIGHT AWAY.

USE

HAND SANITIZER TO HELP REDUCE PATHOGENS ON THE SKIN

WARNINGS

FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

THIS PRODUCT IS INTENDED FOR EXTERNAL USE ONLY.

DIRECTIONS

• PLACE ENOUGH PRODUCT IN YOUR PALM TO THOROUGHLY COVER YOUR HANDS
• RUB HANDS TOGETHER BRISKLY UNITL DRY
• CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT

OTHER INFORMATION

• STORE BELOW 110 oF (44 oC)
• MAY DISCOLOR CERTAIN FABRICS OR SURFACES

INACTIVE INGREDIENTS

WATER (AQUA), HYDROXYETHYLCELLULOSE, HEMP CBD

ASTRAL ORGANICA HAND SANITIZER WITH CBD 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73369-0011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	64.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)	1.2 g  in 100 g
CANNABIDIOL (UNII: 19GBJ60SN5)	0.23 g  in 100 g
WATER (UNII: 059QF0KO0R)	33.87 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73369-0011-1	43.4 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/02/2020	01/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/02/2020	01/01/2022

Labeler - Kabana Skin Care (080237112)

Registrant - Kabana Skin Care (080237112)

Establishment
Name	Address	ID/FEI	Business Operations
Kabana Skin Care		080237112	manufacture(73369-0011)

Revised: 11/2022

Document Id: ecbe7707-3089-3a24-e053-2a95a90a0769

34390-5

Set id: abec44cf-0c4c-71c2-e053-2995a90a3c2e

Version: 4

Effective Time: 20221105