BRUCKE A.C.C. CALMING MIST- glycerin liquid

Brucke A.C.C. Calming Mist by

Drug Labeling and Warnings

Brucke A.C.C. 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, etc.

PURPOSE

Skin Protectant

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

20cm apart from the desired area. Spray frequently whenever you feel tight and sensitive after cleansing.

WARNINGS

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).

1) Occurrence of red spots, swelling, itchiness, and other skin irritation

2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other skin irritations

3. Precaution for Storage and Handling

1) Close the lid after use

2) Keep out of reach of infants and children

3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRUCKE A.C.C. CALMING MIST 
glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71380-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71380-0003-1	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/15/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	05/15/2017

Labeler - Nature4 co., Ltd. (694208420)

Registrant - Nature4 co., Ltd. (694208420)

Establishment
Name	Address	ID/FEI	Business Operations
Nature4 co., Ltd.		694208420	manufacture(71380-0003) , label(71380-0003) , pack(71380-0003)