INTEGRAL B Keep Calming Mist by Nature4 co., Ltd. Drug Facts

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]

INTEGRAL B KEEP CALMING MIST- glycerin liquid 
Nature4 co., Ltd.

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

Glycerin

Water, Butylene Glycol, etc.

Skin Protectant

keep out of reach of the children

Spraying on the face and entire body after cleansing and bathing. Then pat lightly until fully absorbed.

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.

for external use only

INTEGRAL B KEEP CALMING MIST 
glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71380-0005
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: 71380-0005-1	120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/15/2017	12/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	05/15/2017	12/01/2019

Labeler - Nature4 co., Ltd. (694208420)

Registrant - Nature4 co., Ltd. (694208420)

Establishment
Name	Address	ID/FEI	Business Operations
Nature4 co., Ltd.		694208420	manufacture(71380-0005) , label(71380-0005) , pack(71380-0005)

Revised: 12/2019

Document Id: 98da6440-3345-8ec2-e053-2a95a90a3b65

34390-5

Set id: 4fb2840a-3de1-5485-e054-00144ff88e88

Version: 3

Effective Time: 20191203

 

Nature4 co., Ltd.