petrolatum jelly

petrolatum jelly
SPL v3
SPL
SPL Set ID f04337fb-6245-47f2-b2e6-7974feb3f644
Route
topical
Published
Effective Date 2014-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
petrolatum (1 g)

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2015-08-26

Purpose

Skin Protectant

Description

White Petrolatum (USP, 100%  w/w)                    


Medication Information

Purpose

Skin Protectant



Inactive Ingredients

None

Description

White Petrolatum (USP, 100%  w/w)                    

Principal Display Panel

Petroleum Jelly

White Petrolatum 100%

Cardinal Health

NDC 63517-211-05



Net Wt 3.25 oz (92.14g)







Uses:
  • temporarily protects minor * cuts * scrapes * burns
  • temporarily protects and helps relieve chapped and cracked skin or lips
  • helps protect from the drying effects of wind and cold weather

Warnings:

For external use only.

Do Not Use
  • deep or puncture wounds
  • animal bites
  • serious burns

Directions:
  • apply as needed.

Active Ingredient

White Petrolatum (USP, 100%  w/w)                    

Other Information:
  • Store at 59 Deg F - 86 Deg F (15 - 30 Deg C)
  • Avoid excessive heat.

When Using This Product
  • do not get into eyes

Stop Use and Ask A Doctor If
  • condition worsens
  • condition lasts more than 7 days or clears up and occurs again within a few days

Keep Out of Reach of Children.

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




Structured Label Content

Purpose

Skin Protectant



Inactive Ingredients

None

Principal Display Panel

Petroleum Jelly

White Petrolatum 100%

Cardinal Health

NDC 63517-211-05



Net Wt 3.25 oz (92.14g)







Uses:
  • temporarily protects minor * cuts * scrapes * burns
  • temporarily protects and helps relieve chapped and cracked skin or lips
  • helps protect from the drying effects of wind and cold weather

Warnings:

For external use only.

Do Not Use (Do not use)
  • deep or puncture wounds
  • animal bites
  • serious burns

Directions:
  • apply as needed.

Active Ingredient

White Petrolatum (USP, 100%  w/w)                    

Other Information: (Other information:)
  • Store at 59 Deg F - 86 Deg F (15 - 30 Deg C)
  • Avoid excessive heat.

When Using This Product (When using this product)
  • do not get into eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • condition lasts more than 7 days or clears up and occurs again within a few days

Keep Out of Reach of Children. (Keep out of reach of children.)

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




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