BABYSONS- dexpanthenol ointment

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Laboratorios Quimica Son's, S.A. de C.V

Indgivelsesvej:

TOPICAL

Recept type:

OTC DRUG

Terapeutiske indikationer:

- Helps treat and prevent diaper rash - Protects chafed skin due to diaper rash and helps seal out wetness

Autorisation status:

OTC monograph not final

Produktets egenskaber

BABYSONS- DEXPANTHENOL OINTMENT
LABORATORIOS QUIMICA SON'S, S.A. DE C.V
----------
BABYSONS
_DRUG FACTS_
_ACTIVE INGREDIENT_
Dexpanthenol 5%
_PURPOSE_
Skin Protectant
_USES_
Helps treat and prevent diaper rash
Protects chafed skin due to diaper rash and helps seal out wetness
_WARNINGS_
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
do not get into eyes.
STOP USE AND ASK A DOCTOR IF
condition worsens
symptoms last more than 7 days or clear up and occur again within a
few days
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
Change wet and soiled diapers promptly.
Cleanse the diaper area and allow to dry
Apply product liberally as often as necessary, with each diaper
change, especially at
bedtime or anytime when exposure to wet diapers may be prolonged.
_OTHER INFORMATION_
Keep the tube tightly closed and store at no higher temperature than
86°F / 30°C.
_INACTIVE INGREDIENTS_
anhydrous lanolin, beeswax, cetyl alcohol, polysorbate 60, polysorbate
80, stearyl
alcohol, water, white petrolatum, zinc oxide
PACKAGE LABELING:
BABYSONS
dexpanthenol ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:73519-001
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z)
DEXPANTHENOL
50 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
LANOLIN (UNII: 7EV65EAW6H)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
ZINC OXIDE (UNII: SOI2LOH54Z)
PACKAGING
MARKETING START
MARKETING END
Laboratorios Quimica Son's, S.A. de C.V
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:73519-001-
30
1 in 1 BOX
06/15/2020
1
30 g in 1 TUBE; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER