Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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AMERIDERM VITAMIN A D- white petrolatum ointment 
Shield Line 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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Drug Facts

Active Ingredient

White petrolatum USP (76% w/w)

Purpose

Skin Protection

Uses

■ Helps treat and prevent diaper rash ■ helps seal out wetness ■ temporarily protects minor ■ cuts ■ scrapes ■ burns ■ temporarily helps protect and relieve chapped and cracked skin or lips ■ helps prevent and protect from the drying effects of wind and cold weather ■ helps prevent and protect chafed skin or minor skin irritations associated with diaper rash ■ with each diaper change, espicially at bedtime when exposure to wet diapers may be prolonged

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 in 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

For Skin Protection and Diaper rash ■ apply as needed

Additionally when using for Diaper Rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry

Other Information

■ store at 15-30C (59-86F) ■ avoid excessive heat and humidity

Inactive ingredients

lanolin, vitamin A palmitate, vitamin D3 in corn oil, quaternium-15

Package Label

image description

AMERIDERM  VITAMIN A D
white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52410-8036
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
CORN OIL (UNII: 8470G57WFM)  
QUATERNIUM-15 (UNII: E40U03LEM0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52410-8036-2100 g in 1 TUBE; Type 0: Not a Combination Product07/01/2018
2NDC: 52410-8036-3425 g in 1 JAR; Type 0: Not a Combination Product07/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/01/2014
Labeler - Shield Line LLC (078518916)

Revised: 11/2019
 
Shield Line LLC


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