SKIN-LUBE- alcohol ointment

Skin-Lube by

Drug Labeling and Warnings

Skin-Lube by is a Otc medication manufactured, distributed, or labeled by Performance Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 few days.

Directions:

Apply as needed.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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: 59316-995-95

INGREDIENTS AND APPEARANCE

SKIN-LUBE 
alcohol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-995
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-995-21	78 g in 1 JAR; Type 0: Not a Combination Product	05/18/2017
2	NDC: 59316-995-95	11340 g in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2017
3	NDC: 59316-995-96	454 g in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2017
4	NDC: 59316-995-97	2270 g in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/18/2017

Labeler - Performance Health LLC (794324061)