Label: DIAPER RASH BALM- skin protectant ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 61328-001-01 - Packager: Skinfix, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 9, 2013
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Package Label Principal Display
Treats rash, redness & Irritation
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 . Avoid contact with eyes
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 and allow to dry. Apply balm liberally as often as necessary, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
DIAPER RASH BALM
skin protectant ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61328-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.2 g in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) ALCOHOL (UNII: 3K9958V90M) SOYBEAN OIL (UNII: 241ATL177A) SUNFLOWER OIL (UNII: 3W1JG795YI) JOJOBA OIL (UNII: 724GKU717M) WHITE WAX (UNII: 7G1J5DA97F) PARAFFIN (UNII: I9O0E3H2ZE) ALLANTOIN (UNII: 344S277G0Z) BENZOIN RESIN (UNII: GK21SBA74R) LIQUIDAMBAR ORIENTALIS RESIN (UNII: 63V91G4W93) TOLU BALSAM (UNII: TD2LE91MBE) ALOE (UNII: V5VD430YW9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61328-001-01 60 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 12/09/2013 Labeler - Skinfix, Inc. (203158183) Registrant - Product Integrity Laboratory, LLC (783863694) Establishment Name Address ID/FEI Business Operations Canadian Custom Packaging Company 207062514 manufacture(61328-001)