BABYSONS- dexpanthenol ointment 
Laboratorios Quimica Son's, S.A. de C.V

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BABYSONS

Drug Facts

Active ingredient

Dexpanthenol 5%

Purpose

Skin Protectant

Uses

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

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:

Outer PackageInner Package

BABYSONS 
dexpanthenol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73519-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z) DEXPANTHENOL50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73519-001-301 in 1 BOX06/15/2020
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01606/15/2020
Labeler - Laboratorios Quimica Son's, S.A. de C.V (815603378)
Establishment
NameAddressID/FEIBusiness Operations
Laboratorios Quimica Son's, S.A. de C.V815603378manufacture(73519-001)

Revised: 12/2023
Document Id: 0c0e8f59-0e22-854a-e063-6294a90a7663
Set id: 8a4782fc-5917-4f63-b9bf-6597be2afc6c
Version: 3
Effective Time: 20231209
 
Laboratorios Quimica Son's, S.A. de C.V