BALMEX DIAPER RASH- zinc oxide cream

Balmex Diaper Rash by

Drug Labeling and Warnings

Balmex Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Randob Labs,Ltd., KIK HOLDCO COMPANY INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• Active ingredients: Purpose
• Zinc Oxide 11.3%: 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 immediately.

Directions

• change wet or soiled diapers promptly, cleanse the diaper area, and allow to dry
• apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Other information

• do not use if quality seal is broken
• see bottom of carton and or top of tube for lot number and expiration date

INACTIVE INGREDIENT

Inactive ingredients Beeswax, benzoic acid, dimethicone, fragrance, glycine soja (soybean) oil, magnesium aspartate, methylparaben, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europea (olive) leaf extract, panthenol, potassium aspartate, potassium hydroxide, propylparaben, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water (245-230)

Questions?

1-833-389-9450

Dist. by: RANDOB LABS LTD. Box 440, Cornwall, NY 12518

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

NEW LOOK-SAME PRODUCT

Balmex®
COMPLETE
PROTECTION™

Zinc Oxide

DIAPER RASH CREAM

Prevents & Heals

• ✔ Protects against
  all 3 leading causes
  of diaper rash
• ✔ Reduces rash in
  just 1 diaper change

Pediatrician Recommended

Advanced
Formula

NET WT 4 OZ (113 g)

INGREDIENTS AND APPEARANCE

BALMEX DIAPER RASH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52412-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.113 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Yellow Wax (UNII: 2ZA36H0S2V)
Benzoic Acid (UNII: 8SKN0B0MIM)
Dimethicone 100 (UNII: RO266O364U)
Soybean Oil (UNII: 241ATL177A)
Magnesium Aspartate Anhydrous (UNII: 082H981FMA)
Methylparaben (UNII: A2I8C7HI9T)
Microcrystalline Wax (UNII: XOF597Q3KY)
Mineral Oil (UNII: T5L8T28FGP)
Oenothera Biennis (UNII: 76UI55V071)
Olea Europaea Leaf (UNII: MJ95C3OH47)
Dexpanthenol (UNII: 1O6C93RI7Z)
Potassium Aspartate (UNII: OC4598NZEQ)
Potassium Hydroxide (UNII: WZH3C48M4T)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
Sarcosine (UNII: Z711V88R5F)
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)
Tocopherol (UNII: R0ZB2556P8)
Water (UNII: 059QF0KO0R)
Sodium Cocoyl Glycinate (UNII: XLU9KH03XM)
White Wax (UNII: 7G1J5DA97F)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52412-400-04	1 in 1 CARTON	11/01/2018
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 52412-400-16	453 g in 1 JAR; Type 0: Not a Combination Product	11/01/2018
3	NDC: 52412-400-02	1 in 1 CARTON	11/01/2018
3		56 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 52412-400-05	5.1 g in 1 PACKAGE; Type 0: Not a Combination Product	11/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	04/27/2015

Labeler - Randob Labs,Ltd. (061995007)

Establishment
Name	Address	ID/FEI	Business Operations
KIK HOLDCO COMPANY INC.		243547333	MANUFACTURE(52412-400)