Label: RUGBY ZINC OXIDE- zinc oxide ointment
- NDC Code(s): 0536-5700-98
- Packager: Rugby Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- SPL UNCLASSIFIED SECTION
- Active ingredient
Zinc oxide 20%Close
- helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.
- dries the oozing and weeping of poison ivy, poison oak and poison sumac.
For external use only
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
- apply liberally as often as necessary
For diaper rash:
- change wet or soiled diapers promptly
- cleanse the diaper area and allow to dry
- apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged
- Inactive ingredients
mineral oil, petrolatumClose
- Questions or comments?
Call 1-800-645-2158 9 am - 5 pm EST, Monday – Friday
Store at room temperature 15° - 30°C (59° - 86°F).
- PRINCIPAL DISPLAY PANEL
Principal Display Panel – Jar Label
Rugby® NDC 0536-5700-98
• provides soothing relief from poison ivy,
oak and sumac
• Treats and prevents diaper rash
Net Wt 1 lb (454 g)
Mfd for: Rugby Laboratories, Inc.Close
Duluth, Georgia 30097
- INGREDIENTS AND APPEARANCE
RUGBY ZINC OXIDE
zinc oxide ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-5700 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-5700-98 454 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/23/2004 Labeler - Rugby Laboratories (191427277) Registrant - Faria Limited dba Sheffield Pharmaceuticals (151177797) Establishment Name Address ID/FEI Business Operations Faria LLC dba Sheffield Pharmaceuticals 151177797 MANUFACTURE(0536-5700)