BALMEX ADULT CARE RASH- zinc oxide cream

BALMEX ADULT CARE RASH by

Drug Labeling and Warnings

BALMEX ADULT CARE 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

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ACTIVE INGREDIENT

Active Ingredients	Purpose
Zinc Oxide 11.3%	Skin protectant

Uses

• helps relieve and prevent rashes and irritation due to wetness from incontinence
• protects chafed skin due to irritation and helps seal out wetness

Warnings

For external use only

When using this product

• avoid contact with eyes

Stop use and ask a doctor if

• condition worsens
• symptoms persist 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

• gently cleanse affected skin
• pat dry with a clean, soft cloth or allow to air dry
• apply generously to affected area as needed, especially after incontinence episodes
• using a dry tissue to remove excess product from skin is most effective

STORAGE AND HANDLING

INACTIVE INGREDIENT

Inactive ingredients mineral oil, water, beeswax, microcrystalline wax, synthetic beeswax, fragrance, sorbitan sesquioleate, oenothera biennis (evening primrose) seed extract, olea europaea (olive) leaf extract, dimethicone, tocopherol, methylparaben, glycine soja (soybean) oil, propylparaben, panthenol, sarcosine, benzoic acid, potassium aspartate, potassium hydroxide, magnesium aspartate, sodium cocoyl amino acids (309-021) 

QUESTIONS

For more information please visit 
www.BalmexAdult.com

SPL UNCLASSIFIED SECTION

Distributed by RANDOB LABS LTD.
Box 440, Cornwall, NY 12518

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

Activ
Guard™

NEUTRALIZES
IRRITANTS

Balmex®
ADULTCARE™

RASH CREAM
ZINC OXIDE 11.3%

Soothes &
Protects Skin
From Irritation, Chafing & Rash

Dermatologist Tested
Works in One Use*
Odor-Free

NET WT 3 OZ (85 g)

INGREDIENTS AND APPEARANCE

BALMEX ADULT CARE RASH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52412-500
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
Mineral Oil (UNII: T5L8T28FGP)
Water (UNII: 059QF0KO0R)
Yellow Wax (UNII: 2ZA36H0S2V)
Microcrystalline Wax (UNII: XOF597Q3KY)
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)
Oenothera Biennis (UNII: 76UI55V071)
Olea Europaea Leaf (UNII: MJ95C3OH47)
Dimethicone 100 (UNII: RO266O364U)
Tocopherol (UNII: R0ZB2556P8)
Methylparaben (UNII: A2I8C7HI9T)
Soybean Oil (UNII: 241ATL177A)
Propylparaben (UNII: Z8IX2SC1OH)
Dexpanthenol (UNII: 1O6C93RI7Z)
Sarcosine (UNII: Z711V88R5F)
Benzoic Acid (UNII: 8SKN0B0MIM)
Potassium Aspartate (UNII: OC4598NZEQ)
Potassium Hydroxide (UNII: WZH3C48M4T)
Magnesium Aspartate Anhydrous (UNII: 082H981FMA)
Sodium Cocoyl Glycinate (UNII: XLU9KH03XM)
Propylene Glycol (UNII: 6DC9Q167V3)
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: 52412-500-03	1 in 1 CARTON	11/01/2018
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 52412-500-12	340 g in 1 JAR; 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(52412-500)