GLUTA PRIMME BODY OIL oil

GLUTA PRIMME body oil by

Drug Labeling and Warnings

GLUTA PRIMME body oil by is a Otc medication manufactured, distributed, or labeled by Guangzhou Kadiya Biotechnology Co. Ltd., Guangzhou Kadiya Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active Ingredients
GLUTATHIONE0.2%
Alpha Arbutin0.1%

PURPOSE

For skin brightening and moisturising

Warning

1.Before use, perform a skin test on your arm and discontinue use if you have allergy symptoms or skin abnormalities.
2、For external use only, avoid contact with eyes when used
3、Keep out of reach of children

INACTIVE INGREDIENT

MINERAL OIL、ISONONYL ISONONANOATE、TRICAPRIN、ETHYLHEXYL PALMITATE、CI 47000

USAGE

For skin brightening and moisturising

Dosage

AFTER SHOWER OR BATH: While skin is still damp, smooth on a few drops to help seal in moisture. Let your body dry naturally, or simply pat dry with a towel. IN THE BATH: Add to water and soften your skin while you bathe.

Warning

Out of reach of children

PRINCIPAL DISPLAY PANEL

Drug Facts
Active Ingredients
GLUTATHIONE0.2%
Alpha Arbutin0.1%

Uses：
For skin brightening and moisturising
The storage method：
Store sealed in a cool place and out of sunlight
Warning.
1.Before use, perform a skin test on your arm and discontinue use if you have allergy symptoms or skin abnormalities.
2、For external use only, avoid contact with eyes when used
3、Keep out of reach of children
Inactive ingredients：
MINERAL OIL、ISONONYL ISONONANOATE、TRICAPRIN、ETHYLHEXYL PALMITATE、CI 47000

INGREDIENTS AND APPEARANCE

GLUTA PRIMME BODY OIL 
gluta primme body oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84423-009
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALPHA-ARBUTIN (UNII: 72VUP07IT5) (ALPHA-ARBUTIN - UNII:72VUP07IT5)	ALPHA-ARBUTIN	0.2 mg  in 200 mg
GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O)	GLUTATHIONE	0.4 mg  in 200 mg

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
D&C YELLOW NO. 11 (UNII: 44F3HYL954)
TRICAPRIN (UNII: O1PB8EU98M)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ETHYLHEXYL PALMITATE (UNII: 2865993309)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84423-009-01	200 mg in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	06/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	06/29/2024

Labeler - Guangzhou Kadiya Biotechnology Co. Ltd. (713172913)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Kadiya Biotechnology Co., Ltd.		713172913	manufacture(84423-009)