RESINOL- petrolatum and resorcinol ointment

Resinol by

Drug Labeling and Warnings

Resinol by is a Otc medication manufactured, distributed, or labeled by ResiCal, Inc., Aurora Labs LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Petrolatum 55%, Resorcinol 2%

Uses

• temporarily protects minor
  • cuts
  • scrapes
  • burns
• temporarily relieves pain and itching associated with
  • minor skin irritations
  • minor burns
  • sunburn
  • minor cuts
  • scrapes
  • insect bites
  • rashes due to poison ivy, oak, and sumac

Warnings

For external use only

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• do not get into eyes
• do not apply over large areas of the body

Stop use and ask a doctor if

• condition worsens
• symptoms last 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.

Directions

• adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
• children under 2 years: ask a doctor

Inactive ingredients

calamine, corn starch, lanolin, zinc oxide

Questions or comments?

1-800-204-6434      www.resinol.com

SPL UNCLASSIFIED SECTION

Distributed by: ResiCal, Inc.
Orchard Park, NY 14127

PRINCIPAL DISPLAY PANEL - 93.6 g Jar Label

Resinol®

Topical Analgesic/Skin Protectant
MEDICATED OINTMENT

For fast soothing relief of
MINOR SKIN IRRITATIONS

NET WT 3.3 OZ (93.6 g)

INGREDIENTS AND APPEARANCE

RESINOL 
petrolatum and resorcinol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67492-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	55 g  in 100 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
LANOLIN (UNII: 7EV65EAW6H)
ZINC OXIDE (UNII: SOI2LOH54Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67492-105-12	93.6 g in 1 JAR; Type 0: Not a Combination Product	06/29/2002
2	NDC: 67492-105-11	35.4 g in 1 JAR; Type 0: Not a Combination Product	06/29/2002
3	NDC: 67492-105-13	25.5 g in 1 JAR; Type 0: Not a Combination Product	06/29/2002
4	NDC: 67492-105-14	85.1 g in 1 JAR; Type 0: Not a Combination Product	06/29/2002

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/29/2002

Labeler - ResiCal, Inc. (927081369)

Establishment
Name	Address	ID/FEI	Business Operations
Aurora Labs LLC.		176110547	MANUFACTURE(67492-105)