BALMEX DIAPER RASH- zinc oxide 11.3% cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Randob Labs, LTD

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Protectant Helps treat and prevent diaper rash, protects chafed skin due to diaper rash and helps seal out wetness.

Authorization status:

OTC monograph final

Summary of Product characteristics

BALMEX DIAPER RASH- ZINC OXIDE 11.3% CREAM
RANDOB LABS, LTD
_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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BALMEX DIAPER RASH CREAM
Zinc Oxide 11.3%
Skin Protectant
Helps treat and prevent diaper rash, protects chafed skin due to
diaper rash and helps
seal out wetness.
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.
If swallowed, seek medical help or contact a Poison Control Center
immediately.
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.
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.
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: 8P5F881