Label: ASTONEA PETROLATUM- petrolatum ointment
77338-211-04, view more77338-211-05, 77338-211-06
- Packager: ASTONEA LABS PRIVATE LIMITED
- 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.
Updated January 12, 2023
If you are a consumer or patient please visit this version.
- Active Ingredient (in each gram)
- Helps treat and prevent diaper rash
- Helps seal out wetness
- Temporarily protects minor cuts, scrapes and burns
- Temporarily helps protect and helps relieve chapped and cracked skin or lips
- Helps prevent and protect from the drying effects of wind and cold weather
- Helps prevent and protect from chafed skin or mionr skin irritations associated with diaper rash, with each diaper change, especially at bedtime when exposure to wet diapers may be prolonged
For External Use Only.
Stop use and ask a doctor if
- The condition persists or gets worse
- Symptoms persists for more than 7 days or clear up and occur again within a few days.
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
- Store at controlled room temperature 15 o - 30 oC(59 o--86 o F)
- Avoid excessive heat and humidity
- Tamper evident
- Do not use if packet is torn, cut or opened
- Inactive Ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77338-211 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:77338-211-01 5 g in 1 PACKET; Type 0: Not a Combination Product 02/22/2013 2 NDC:77338-211-02 56.6 g in 1 TUBE; Type 0: Not a Combination Product 02/05/2013 3 NDC:77338-211-03 368.5 g in 1 JAR; Type 0: Not a Combination Product 02/05/2013 4 NDC:77338-211-04 226 g in 1 JAR; Type 0: Not a Combination Product 02/01/2023 5 NDC:77338-211-05 368 g in 1 JAR; Type 0: Not a Combination Product 02/01/2023 6 NDC:77338-211-06 425 g in 1 JAR; Type 0: Not a Combination Product 02/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 02/05/2013 Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)