BADGER ESSENTIAL BABY SET- zinc oxide 
W.S. Badger Company, Inc.

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.

----------

Set EOM's; Badger ® Essential Baby Set

Active Ingredient

Zinc oxide 10%

Purpose

Skin Protectant

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

Uses

■ Treats and prevents diaper rash ■ Soothes irritated skin ■ Protects against moisture

Directions

■ Cleanse area, pat dry, then apply an even layer of cream ■ Use every day or if rash is present

*Helianthus Annuus (Sunflower) Seed Oil, *Cera Alba (Beeswax), *Calendula Officinalis (Calendula) Flower Extract, Tocopherol (Sunflower Vitamin E). * = Certified Organic

Warnings

For external use only

When using this product

When using this product: Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

Stop use and ask a doctor if: Rash or irritation develops and lasts. Condition persists for more than 7 days.

Diaper Cream

Keeps skin soft and dry. Zinc Oxide treats and prevents diaper rash.

Carton

BADGER ESSENTIAL BABY SET 
zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62206-3360
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62206-3360-11 in 1 KIT; Type 0: Not a Combination Product06/21/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 87 mL
Part 21 CAN 21 g
Part 31 BOTTLE 118 mL
Part 1 of 3
BADGER DIAPER 
zinc oxide cream
Product Information
Item Code (Source)NDC:62206-2850
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TOCOPHEROL (UNII: R0ZB2556P8)  
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62206-2850-187 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/02/2015
Part 2 of 3
BABY BALM  BADGER
lotions, oils, powders, and creams cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGROLIVE OIL (UNII: 6UYK2W1W1E)  
INGRYELLOW WAX (UNII: 2ZA36H0S2V)  
INGRCASTOR OIL (UNII: D5340Y2I9G)  
INGRCALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
INGRCHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
121 g in 1 CAN; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic06/21/2017
Part 3 of 3
BABY OIL  BADGER
lotions, oils, powders, and creams oil
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGROLIVE OIL (UNII: 6UYK2W1W1E)  
INGRJOJOBA OIL (UNII: 724GKU717M)  
INGRCALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
INGRCHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic06/21/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/21/2017
Labeler - W.S. Badger Company, Inc. (963242326)
Establishment
NameAddressID/FEIBusiness Operations
W.S. Badger Company, Inc.963242326manufacture(62206-3360)

Revised: 12/2022
Document Id: d10405f8-2fa3-92c1-e053-2995a90a691c
Set id: 527f206f-9361-1ade-e054-00144ff8d46c
Version: 5
Effective Time: 20221219
 
W.S. Badger Company, Inc.