ASTONEA PETROLATUM- petrolatum ointment

ASTONEA PETROLATUM by

Drug Labeling and Warnings

ASTONEA PETROLATUM by is a Otc medication manufactured, distributed, or labeled by ASTONEA LABS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each gram)

White Petrolatum, USP, 100% w/w

Purpose

Skin Protectant

Uses

• 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

Directions

• Change wet and soiled diapers promptly
• Cleanse the diaper area and allow to dry
• Apply as needed

Warnings

For External Use Only.

Do not use on

• Deep or puncture wounds
• Animal bites
• Serious burns

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.

Other information

• 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
  

When using this product

• Do not get into eyes

Inactive Ingredients

None

Principal Display Panel

INGREDIENTS AND APPEARANCE

ASTONEA PETROLATUM 
petrolatum ointment

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
7	NDC: 77338-211-07	113 g in 1 TUBE; Type 0: Not a Combination Product	02/05/2013
8	NDC: 77338-211-08	100 g in 1 JAR; Type 0: Not a Combination Product	02/05/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	02/05/2013

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)