Your browser does not support JavaScript! BABY HEALING (PETROLATUM) OINTMENT [AMERICAN SALES COMPANY]
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BABY HEALING (petrolatum) ointment
[American Sales Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active ingredient

Petrolatum 41%

Purpose

Skin protectant (ointment)

Keep Out of Reach of Children

Uses

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

Warnings

For external use only. 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 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, glycerin, panthenol (pro-viatmin B5), bisabolol.

Package/Label Principal Display Panel

Cottontails baby care healing ointment

advanced treatment for cracked, dry or irritated skin

*Compare to Eucerin® Aquaphor® Baby Healing Ointment Ingredients

NET WT 3 OZ (85 g)

  • Skin Protectant
  • Non-Irritating
  • Restores healthy skin

*This product is not manufactured or distributed by Beiersdorf Inc. owner of the registered trademark Eucerin® Aquaphor®.

DISTRIBUTED BY FOODHOLD, U.S.A., LLC
LANDOVER, MD 20785 1-877-846-9949
© 2013 Ahold Licensing, Sarl

MADE IN ISRAEL

Quality guaranteed or your money back.

BD521 D4 T1

Baby Care Healing Ointment Label

Tube Label

BABY HEALING 
petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-522
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM41 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
CERESIN 
LANOLIN 
GLYCERIN 
PANTHENOL 
LEVOMENOL 
ALCOHOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-522-1185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/13/2013
Labeler - American Sales Company (809183973)

Revised: 9/2013
 
American Sales Company

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