BALMEX DIAPER RASH- zinc oxide 11.3% 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, Derma Care Research Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 11.3%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

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, seek medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Change wet and 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 anytime when exposure to wet diapers may be prolonged.

INACTIVE INGREDIENT

Beeswax, benzoic acid, dimethicone, glycine soja (soybean) oil, magnesium aspartate, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europae (olive) leaf extract, panthenol, Peruvian balsam, Phenoxyethanol, potassium aspartate, potassium hydroxide, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BALMEX DIAPER RASH 
zinc oxide 11.3% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52412-285
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
SOYBEAN OIL (UNII: 241ATL177A)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MINERAL OIL (UNII: T5L8T28FGP)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
PANTHENOL (UNII: WV9CM0O67Z)
BALSAM PERU (UNII: 8P5F881OCY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM ASPARTATE (UNII: OC4598NZEQ)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SARCOSINE (UNII: Z711V88R5F)
COCO ACID CHLORIDES (UNII: R7N8Y0XMX7)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
YELLOW WAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52412-285-16	453 g in 1 JAR; Type 0: Not a Combination Product	04/19/2021
2	NDC: 52412-285-12	340 g in 1 JAR; Type 0: Not a Combination Product	04/19/2021
3	NDC: 52412-285-04	1 in 1 CARTON	04/19/2021
3		113 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 52412-285-02	1 in 1 CARTON	04/19/2021
4		56 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 52412-285-03	1 in 1 CARTON	04/04/2023
5		85 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	M016	04/19/2021

Labeler - Randob Labs, LTD (061995007)

Registrant - Derma Care Research Labs (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs		116817470	manufacture(52412-285)