SOOTHE AND COOL FREE MOISTURE BARRIER

Main information

  • Trade name:
  • SOOTHE AND COOL FREE MOISTURE BARRIER- petrolatum ointment
  • Composition:
  • PETROLATUM 92.8 g in 100 g
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SOOTHE AND COOL FREE MOISTURE BARRIER- petrolatum ointment
    United States
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 53329-072-16, 53329-072-96
  • Last update:
  • 29-05-2019

Summary of Product characteristics: dosage, interactions, side effects

SOOTHE AND COOL FREE MOISTURE BARRIER- petrolatum ointment

Medline Industries, Inc.

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.

----------

Drug Facts

Active ingredient

Petrolatum 92.8%

Purpos e

Skin Protectant

Us es

Temporarily protects minor:

cuts

scrapes

burns

temporarily protects and helps chapped or cracked skin and lips

helps 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 for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

cleanse skin

apply ointment as needed

Other Information

Store at controlled room temperature 15 to 30 C (59 to 86 F)

Tamper evident. Do not use if packet is torn, cut or opened.

Avoid excessive heat and humidity

Inactive ingredients

Aloe Barbadensis Leaf Juice (Aloe Vera), Benzethonium Chloride, Cholecalciferol (Vitamin D 3),

Isopropyl Myristate, Octyl Hydroxystearate, Propylene Glycol, Retinyl Palmitate (Vitamin A)

Package Label - packet

Protect

NDC 53329-072-16

Soothe&Cool®

Free

Moisture Barrier Ointment

with Aloe & Vitamins A & D

Protecting Skin From Prolonged Exposure to Moisture

REORDER: MSC095384

Medline®

NET. WT. 5 grams

Package Label - box

NDC 53329-072-96

Soothe&Cool® Free

Moisture Barrier Ointment

with Aloe & Vitamins A&D

Protecting Skin From Prolonged Exposure to Moisture

REORDER: MSC095384

MEDLINE

NET. WT. 5 grams

144 Each per Box

Medline Industries, Inc.

SOOTHE AND COOL FREE MOISTURE BARRIER

petrolatum ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:53329 -0 72

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U) (PETROLATUM - UNII:4T6 H12BN9 U)

PETROLATUM

9 2.8 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

BENZETHO NIUM CHLO RIDE (UNII: PH41D0 5744)

CHO LECALCIFERO L (UNII: 1C6 V77QF41)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:53329 -0 72-9 6

144 in 1 CARTON

1

NDC:53329 -0 72-16

5 g in 1 PACKET

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

0 1/0 1/20 0 7

Labeler -

Medline Industries, Inc. (025460908)

Revised: 5/2010