EROS AQUA SENSATIONS AND CARE WOMAN panthenol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z)

Available from:

MEGASOL COSMETIC GMBH

INN (International Name):

DEXPANTHENOL

Composition:

DEXPANTHENOL 0.5 g in 100 mL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

EROS AQUA SENSATIONS AND CARE WOMAN- PANTHENOL GEL
MEGASOL COSMETIC GMBH
_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._
----------
ACTIVE INGREDIENT
PANTHENOL 0.5%
PURPOSE
SKIN PROTECTANT
USES
HELPS LUBRICATING IN BODY MASSAGE
WARNING:
FOR EXTERNAL USE ONLY
KEEP OUT OF REACH OF CHILDREN
DIRECTIONS FOR USE:
APPLY EROS AQUA SENSATION AND CARE TO ANY AREA OF THE BODY WHERE
EXTRA MOISTURE IS DESIRED.
WASHES OFF EASILY WITH SOAP AND WATER.
RESEAL CAREFULLY AFTER USE.
INACTIVE INGREDIENTS: AQUA (WATER), BUTYLENE GLYCOL, PROPYLENE GLYCOL,
HYDROXYETHYLCELLULOSE, ALOE BARBADENSISLEAF JUICE, LACTIC ACID
EROS AQUA SENSATIONS AND CARE WOMAN
panthenol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:5338 9 -321
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
DEXPANTHENO L (UNII: 1O6 C9 3RI7Z) (DEXPANTHENOL - UNII:1O6 C9 3RI7Z)
DEXPANTHENOL
0 .5 g in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
HYDRO XYETHYL CELLULO SE ( 10 0 MPA.S AT 2 %) (UNII: R33S7TK2EP)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
LACTIC ACID (UNII: 33X0 4XA5AT)
MEGASOL COSMETIC GMBH
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:5338 9 -321-13
10 0 mL in 1 TUBE
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 12
LABELER -
MEGASOL COSMET IC GMBH (344152855)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
MEGASOL COSMETIC GMBH
3441528 55
ma nufa c ture (5338 9 -321)
Revised: 11/2012