INTEGRAL B KEEP CALMING MIST- glycerin liquid

INTEGRAL B Keep Calming Mist by

Drug Labeling and Warnings

INTEGRAL B Keep Calming Mist by is a Otc medication manufactured, distributed, or labeled by Nature4 co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Glycerin

INACTIVE INGREDIENT

Water, Butylene Glycol, PHELLODENDRON AMURENSE BARK EXTRACT, etc.

PURPOSE

Skin Protectant

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

After cleansing your face and showering when feeling dryness, spray it on your dry face, body, and other parts, and tap it lightly to make it absorb.

WARNINGS

1. In case of having side effects such as red rash, swollenness and/or itching while using this cosmetic, or in case such symptoms appear by direct sunlight after using it, consult a dermatologist immediately.
2. Do not apply on skin where there is wound, eczema, or irritation.
3. Storage and cautions for handling.
A) Keep out of reach of children.
B) Avoid the place where the direct sunlight is.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INTEGRAL B KEEP CALMING MIST 
glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71380-0010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71380-0010-1	120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	10/01/2019

Labeler - Nature4 co., Ltd. (694208420)

Registrant - Nature4 co., Ltd. (694208420)

Establishment
Name	Address	ID/FEI	Business Operations
Nature4 co., Ltd.		694208420	manufacture(71380-0010) , label(71380-0010) , pack(71380-0010)