SKIN-LUBE- alcohol ointment 
Performance Health, LLC

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.

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Skin-Lube Ointment

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

Label11

SKIN-LUBE 
alcohol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-995
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM850 mg  in 1 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE15 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ZINC STEARATE (UNII: H92E6QA4FV)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-995-2178 g in 1 JAR; Type 0: Not a Combination Product05/18/201712/31/2024
2NDC:59316-995-9511340 g in 1 BOTTLE; Type 0: Not a Combination Product05/18/201712/31/2024
3NDC:59316-995-96454 g in 1 BOTTLE; Type 0: Not a Combination Product05/18/201712/31/2024
4NDC:59316-995-972270 g in 1 BOTTLE; Type 0: Not a Combination Product05/18/201712/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/18/201712/31/2024
Labeler - Performance Health, LLC (794324061)

Revised: 8/2022
Document Id: e5b3695c-7190-66de-e053-2a95a90a68c5
Set id: eb42e07b-5a09-44b9-a601-f1fa0b7f6148
Version: 6
Effective Time: 20220807
 
Performance Health, LLC