BABYSONS- dexpanthenol ointment

BABYSONS by

Drug Labeling and Warnings

BABYSONS by is a Otc medication manufactured, distributed, or labeled by Laboratorios Quimica Son's, S.A. de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

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
#	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 or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/15/2020

Labeler - Laboratorios Quimica Son's, S.A. de C.V (815603378)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratorios Quimica Son's, S.A. de C.V		815603378	manufacture(73519-001)