Label: PETROLATUM jelly
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Contains inactivated NDC Code(s)
NDC Code(s): 67777-400-01, 67777-400-02, 67777-400-03, 67777-400-04 - Packager: Dynarex Corporation
- Category: HUMAN OTC DRUG LABEL
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 13, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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Uses:
- Helps treat and prevent diaper rash
- Helps seal out wetness
- Temporarily protects minor * cuts * scrapes * burns
- Temporarily helps protect and helps relieve chapped and cracked skin and lips
- Helps prevent and protect from the drying effects of wind and cold weather
- Helps prevent and protect chaffed skin or minor skin irritations associated with diaper rash
- With each diaper change, especially at bed time when exposure to wet diapers may be prolonged.
- Warnings:
- When using this product:
- Stop use and ask a doctor if:
- Do not use on:
- Keep out of reach of children
- Directions:
- Other information:
- Indications and Usage
- Principal Display Panel:
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INGREDIENTS AND APPEARANCE
PETROLATUM
petrolatum jellyProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67777-400-01 12 in 1 CASE 1 6 in 1 BOX 1 113.4 g in 1 TUBE 2 NDC:67777-400-02 12 in 1 CASE 2 6 in 1 BOX 2 28.35 g in 1 TUBE 3 NDC:67777-400-03 12 in 1 CASE 3 6 in 1 BOX 3 58.7 g in 1 TUBE 4 NDC:67777-400-04 12 in 1 CASE 4 425.2 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/23/2010 Labeler - Dynarex Corporation (008124539) Registrant - Dynarex Corporation (008124539) Establishment Name Address ID/FEI Business Operations Galentic PharmaIndia Private Limited 918531450 manufacture(67777-400) Establishment Name Address ID/FEI Business Operations Amar Remedies Limited 915839811 manufacture(67777-400)