DRY SKIN TREATMENT STUDIO 35- petrolatum 41% ointment
Walgreens

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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Studio 35 Dry Skin Treatment

Active Ingredient Purpose

Petrolatum 41% Skin protectant (ointment)

Uses

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

Warnings

For external use only

When using this product

When using this product do not get into eyes

Stop use and ask doctor if

Condition worsens, simptoms last more than 7 days or clear up and occur again within a few days

Do not use on

Deep or puncture wounds, animal bites, serious burns

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

Do not use if inner seal is broken or missing

Inactive ingredients

Mineral Oil, Ceresin, Lanolin Alcohol

image description

DRY SKIN TREATMENT STUDIO 35
petrolatum 41% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-3102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	41 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
Ceresin (UNII: Q1LS2UJO3A)
Lanolin Alcohols (UNII: 884C3FA9HE)
Mineral Oil (UNII: T5L8T28FGP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-3102-06	396 g in 1 JAR; Type 0: Not a Combination Product	02/15/2013	03/01/2018
2	NDC:0363-3102-02	50 g in 1 TUBE; Type 0: Not a Combination Product	02/15/2013	03/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	02/15/2013	03/01/2018

Labeler - Walgreens (008965063)

Registrant - Product Quest Mfg, LLC (927768135)

Name	Address	ID/FEI	Business Operations
Establishment
Product Quest Mfg, LLC		927768135	manufacture(0363-3102) , label(0363-3102)

Revised: 3/2018

Document Id: 1ce104d6-8222-41eb-afe7-3cb2db45be8d

Set id: 5aea89fe-9653-44e9-a1d6-a426efb3355d

Version: 2

Effective Time: 20180305

Walgreens