BABYGANICS HINEY HELPER SOOTHING DIAPER- zinc oxide cream 
KAS Direct LLC dba BabyGanics

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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BabyGanics® Hiney Helper Soothing Diaper Cream

Drug Facts

Active ingredient

Zinc oxide 15%

Purpose

Skin protectant

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash
  • 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
  • allow to dry
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

Store at room temperature 59-77°F (15-25°C)

Inactive ingredients

water, butyrospermum parkii (shea) butter, theobroma cacao (cocoa) seed butter, prunus amygdalus dulcis (sweet almond) oil, glycol stearate, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3 polyricinoleate, glycerin, tocopheryl acetate, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil, rubus idaeus (red raspberry) seed oil, calendula officinalis flower extract, aloe barbadensis leaf juice, sorbitan sesquioleate, cetyl ricinoleate, glyceryl caprate, beeswax, sodium polyacryloyldimethyl taurate, hydroxyethylcellulose, hydrogenated polydecene, trideceth-10, butylene glycol, magnesium stearate, aluminum tristearate, sodium benzoate, gluconolactone

Dist. by:
KAS Direct, LLC.
Hicksville, NY 11801

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

PEDIATRICIAN & DERMATOLOGIST
TESTED

BabyGanics®

Hypoallergenic • Vitamin E & Aloe
HINEY HELPER

SOOTHING
Diaper
Rash
Cream

NeoNourish
Complex™

100% Natural Seed Oil

Zinc Oxide Formula
Treats, Protects &
Promotes Healing

No Fragrance, Parabens,
Sulfates, Phthalates
or Toxins

Skin Soothing Formula
with Natural Calendula
& Jojoba

4 OZ (113 g)

Principal Display Panel - 113 g Tube Carton
BABYGANICS HINEY HELPER SOOTHING DIAPER 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59062-1219
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SHEANUT OIL 
GLYCOL STEARATE 
JOJOBA OIL 
POLYGLYCERYL-3 RICINOLEATE 
GLYCERIN 
.ALPHA.-TOCOPHEROL ACETATE 
TOMATO SEED OIL 
SUNFLOWER OIL 
CRANBERRY SEED OIL 
NIGELLA SATIVA SEED OIL 
RASPBERRY SEED OIL 
CALENDULA OFFICINALIS FLOWER 
ALOE VERA LEAF 
SORBITAN SESQUIOLEATE 
CETYL RICINOLEATE 
GLYCERYL CAPRATE 
YELLOW WAX 
SODIUM TAURATE 
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) 
HYDROGENATED POLYDECENE (550 MW) 
TRIDECETH-10 
BUTYLENE GLYCOL 
MAGNESIUM STEARATE 
ALUMINUM STEARATE 
SODIUM BENZOATE 
GLUCONOLACTONE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59062-1219-11 in 1 CARTON
1113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34706/21/2013
Labeler - KAS Direct LLC dba BabyGanics (002764605)

Revised: 7/2013
Document Id: 46444426-db74-4d40-a842-482c78049970
Set id: 253c4065-bb58-413f-8ee4-dbd1576f33ae
Version: 1
Effective Time: 20130719
 
KAS Direct LLC dba BabyGanics