THERAPLEX HEALING EMOLLIENT- petrolatum cream 
The Theraplex Company, 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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theraplex HEALING EMOLLIENT

Drug Facts

Active Ingredient

Petrolatum (65%)

Purpose

Skin Protectant

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

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

Warnings  For external use only

When using this product do not get into eyes.

Stop and ask a doctor if  • condition worsens • symptoms 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

Directions  apply as needed, or as directed by your doctor.

Inactive Ingredients  cyclomethicone, microcrystalline wax

Other information  • store at room temperature • keep from freezing

Questions?   call 1-888-437-2753

Clinically-proven Theraplex Healing Emollient combines a unique enriched special petrolatum fraction (ESPF) with a novel hydrosilicone delivery system that deeply penetrates severely dry skin. Dermatologists have recommended this healing formulation for years because of its ability to deliver soothing moisturization and long-lasting skin barrier protection with no irritation to sensitive, compromised skin.

• Noncomedogenic (Won't Clog Pores)

• Hypoallergenic

• Preservative-Free

• Fragrance-Free

• Paraben-Free

• Gluten-Free

Skin Protectant • For Severely Dry & Sensitive Skin

Dermatologist recommended for adults & children

Net Wt.  8oz. (226.7g)

Distributed by:

The Theraplex Company, LLC

Memphis, TN 38119

www.theraplex.com

Packaging

ther1

THERAPLEX  HEALING EMOLLIENT
petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62917-065
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM65 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62917-065-08226.7 g in 1 JAR; Type 0: Not a Combination Product10/23/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/23/2015
Labeler - The Theraplex Company, LLC (363529392)
Establishment
NameAddressID/FEIBusiness Operations
Memphis Contract Packaging, Inc.185390010manufacture(62917-065)

Revised: 10/2015
Document Id: 91199a78-e92e-487e-8417-f0c5ee60d6d2
Set id: e76e2f90-8c10-4354-8dfe-b4358018645c
Version: 1
Effective Time: 20151023
 
The Theraplex Company, LLC