INTEGRAL B KEEP CALMING MIST- glycerin liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)

Available from:

Nature4 co., Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Protectant 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.

Authorization status:

OTC monograph not final

Summary of Product characteristics

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._
----------
DRUG FACTS
Glycerin
Water, Butylene Glycol, PHELLODENDRON AMURENSE BARK EXTRACT, etc.
Skin Protectant
keep out of reach of the children
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.
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.
for external use only
INTEGRAL B KEEP CALMING MIST
glycerin liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:7138 0 -0 0 10
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
GLYCERIN (UNII: PDC6 A3C0 OX) (GLYCERIN - UNII:PDC6 A3C0 OX)
GLYCERIN
1.5 g in 10 0 mL
Nature4 co., Ltd.
GLYCERIN (UNII: PDC6 A3C0 OX) (GLYCERIN - UNII:PDC6 A3C0 OX)
GLYCERIN
1.5 g in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)
WATER (UNII: 0 59 QF0 KO0 R)
PHELLO DENDRO N AMURENSE BARK (UNII: PBG27B754G)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:7138 0 -0 0 10 -
1
120 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n
Pro duc t
10 /0 1/20 19
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph no t final
pa rt347
10 /0 1/20 19
LABELER -
Nature4 co., Ltd. (694208420)
REGISTRANT -
Nature4 co., Ltd. (694208420)
ESTABLISH