Drug Facts

Active Ingredients

Petrolatum 85%

Dimethicone 1.5%

Purpose

Skin Protectant

Uses

Temporarily protects minor • cuts • scrapes • burns – Helps prevent, temporarily protects, and helps relieve chafed, chapped or cracked skin. Helps prevent and protect from the drying effects of wind and cold weather.

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.

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

Apply as needed.

Other Information

– Store in a cool dry place with lid closed tightly.

Inactive Ingredients

– Diazolidinyl Urea, Methylparaben, Propylene Glycol, Propylparaben, Zinc Stearate

Questions?

(800) 345-2231

Package Labeling:82345-860-25

Label2

Package Labeling:82345-860-05

Label3

Package Labeling:82345-860-01

Label4

Package Labeling:82345-860-02

Label5

SKIN-LUBE
petrolatum, dimethicone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82345-860
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	850 mg in 1 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	15 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ZINC STEARATE (UNII: H92E6QA4FV)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82345-860-25	1134 g in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2022
2	NDC:82345-860-05	2270 g in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2022
3	NDC:82345-860-01	454 g in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2022
4	NDC:82345-860-02	78 g in 1 JAR; Type 0: Not a Combination Product	04/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	04/01/2022

Labeler - The Hygenic Company, LLC. (004163390)

Skin-lube