BABYGANICS DIAPER RASH- zinc oxide cream

BABYGANICS DIAPER RASH by

Drug Labeling and Warnings

BABYGANICS DIAPER RASH by is a Otc medication manufactured, distributed, or labeled by KAS Direct LLC dba BabyGanics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

treats &
protects

babyganics®

diaper rash cream

with zinc oxide, calendula, aloe &
jojoba ∙ helps prevent diaper rash
promotes healing ∙ non allergenic
pediatrician & dermatologist tested

no: parabens, phthalates, petroleum,
mineral oil, dyes or fragrances

+ NeoNourish® Natural Seed Oil Blend

4 OZ (113g)

INGREDIENTS AND APPEARANCE

BABYGANICS DIAPER RASH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-1219
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SHEANUT OIL (UNII: O88E196QRF)
GLYCOL STEARATE (UNII: 0324G66D0E)
JOJOBA OIL (UNII: 724GKU717M)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOMATO SEED OIL (UNII: 7N87T9C06T)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)
RASPBERRY SEED OIL (UNII: 9S8867952A)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CETYL RICINOLEATE (UNII: 1P677500YD)
GLYCERYL CAPRATE (UNII: 197M6VFC1W)
YELLOW WAX (UNII: 2ZA36H0S2V)
SODIUM TAURATE (UNII: Y7LJA74T0N)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
TRIDECETH-10 (UNII: G624N6MSBA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLUCONOLACTONE (UNII: WQ29KQ9POT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59062-1219-1	1 in 1 CARTON	06/21/2013
1		113 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
OTC MONOGRAPH FINAL	part347	06/21/2013

Labeler - KAS Direct LLC dba BabyGanics (002764605)