Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z)
Laboratorios Quimica Son's, S.A. de C.V
TOPICAL
OTC DRUG
- Helps treat and prevent diaper rash - Protects chafed skin due to diaper rash and helps seal out wetness
OTC monograph not final
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 Przeczytaj cały dokument