BODY CARE GIFT SET- zinc oxide 
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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.

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Kit containing diaper rash cream for 2016

Active Ingredients

Zinc Oxide: 19%

Purpose

Skin Protectant

Uses

* Helps treat and prevent diaper rash
* Protects chafed skin associated with diaper rash
* Helps protect against wetness

Warnings

For external use only.

When using this product * avoid contact with eyes.

Stop use and ask a doctor if * condition worsens * symptoms last more than 7 days or clear up and return 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 or soiled diaper promptly. * Cleanse the diaper area and allow to dry. * Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged.

Inactive Ingredients

Helianthus Annuus (Sunflower) Seed Oil (1), Beeswax (1), Glyceryl Dibehenate, Tribehenin, Aloe Barbadensis Leaf Juice (1), Glyceryl Behenate, Tocopheryl Acetate, Carthamus Tinctorius (Safflower) Seed Oil (1), Olea Europae (Olive) Fruite Oil (1), Simmondsia Chinensis (Jojoba) Seed Oil (1), Calendula Officialis Flower Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1)(1) Certified Organic Ingredient

Questions?

Questions? Visit giggle.com or call 800-495-8577

Body Care Gift Set

BODY CARE GIFT SET 
zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70306-9804
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70306-9804-91 in 1 KIT03/01/2016
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 355 mL
Part 21 JAR 85 g
Part 31 TUBE 118 mL
Part 1 of 3
FACE AND BODY LOTION 
lotions, oils, powders, and creams lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRGLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
INGRCASTOR OIL (UNII: D5340Y2I9G)  
INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
INGRCHAMOMILE (UNII: FGL3685T2X)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRYELLOW WAX (UNII: 2ZA36H0S2V)  
INGRANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
INGRCARNAUBA WAX (UNII: R12CBM0EIZ)  
INGRHYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Product Characteristics
colorwhiteC48325
flavorVANILLAC73421
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1355 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic03/01/2016
Part 2 of 3
ALL-PURPOSE WONDER BALM 
other baby products ointment
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRCASTOR OIL (UNII: D5340Y2I9G)  
INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
INGRYELLOW WAX (UNII: 2ZA36H0S2V)  
INGRHYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
INGRALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Product Characteristics
colorwhiteC48325
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
185 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic03/01/2016
Part 3 of 3
DIAPER RASH CREAM 
zinc oxide cream
Product Information
Item Code (Source)NDC:70306-1851
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CHAMOMILE (UNII: FGL3685T2X)  
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
JOJOBA OIL (UNII: 724GKU717M)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
Product Characteristics
Colorwhite (Off-White) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70306-1851-4118 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/2016
Labeler - giggle (194045402)

Revised: 2/2016
Document Id: 2b73aa6c-4c38-3b66-e054-00144ff88e88
Set id: 2b73aa6c-4c37-3b66-e054-00144ff88e88
Version: 2
Effective Time: 20160218
 
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