METABOLIC INTENSIVE CARE- adenosine, alpha bisabolol cream 
rootsallo Qwell

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.

----------

ACTIVE INGREDIENTS

Adenosine 0.04%
.ALPHA.-BISABOLOL, (+/-)- 0.5%

PURPOSE

Anti wrinkle, Whitening

Uses

Helps to have balanced skincare with rich nutrition and deep moisturizing effects on the skin.

Warnings

For external use only.
In case of having side effects such as red rash, swollenness and/or itching while using this cosmetic consult a dermatologist immediately.
Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Directions

Apply an appropriate amount on the skin and pat evenly.

Other Information

Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light.

Questions

www.rootsallo.com 82-31-429-0588

Inactive ingredients

Water, Propanediol, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, Isoamyl Laurate, Cetearyl Alcohol, Macadamia Integrifolia Seed Oil, Glycerin, Glyceryl Stearate SE, Cetearyl Olivate, Hydrogenated Vegetable Oil, Hydrogenated Olive Oil, Cetearyl Glucoside, Stearic Acid, Palmitic Acid, Sorbitan Olivate, Chamaecyparis Obtusa Oil, Olea Europaea (Olive) Fruit Oil, Tocopherol, Scutellaria Baicalensis Root Extract, Arginine, Olea Europaea (Olive) Oil Unsaponifiables, p-Anisic Acid, Centella Asiatica Extract, Paeonia Suffruticosa Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Sodium Hyaluronate, Cetyl Alcohol, Stearyl Alcohol, Citric Acid, Polygonum Cuspidatum Root Extract, Aloe Barbadensis Leaf Extract, Xanthan Gum, Camellia Sinensis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Bioflavonoids, Beta-Glucan, Brassica Oleracea Italica (Broccoli) Extract, *Limonene (essential oil component)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

METABOLIC INTENSIVE CARE 
adenosine, alpha bisabolol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82450-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Adenosine (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) Adenosine0.04 g  in 100 mL
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) (.ALPHA.-BISABOLOL, (+/-)- - UNII:36HQN158VC) .ALPHA.-BISABOLOL, (+/-)-0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propanediol (UNII: 5965N8W85T)  
SHEA BUTTER (UNII: K49155WL9Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82450-020-021 in 1 CARTON12/01/2021
1NDC:82450-020-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/2021
Labeler - rootsallo Qwell (695495466)
Registrant - rootsallo Qwell (695495466)
Establishment
NameAddressID/FEIBusiness Operations
Elan Cosmetic Co.,ltd688204926manufacture(82450-020)

Revised: 12/2021
Document Id: a8c04c10-2ddc-408b-a1b4-b8ec072abe65
Set id: cba70640-3dc4-4af2-a087-0ec19a8ba55c
Version: 1
Effective Time: 20211230
 
rootsallo Qwell