VITAMIN A AND D- lanolin and petrolatum ointment 
Family Dollar Services 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.

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Vitamin A and D Ointment

Active Ingredients

Lanolin         15.5%

Petrolatum   53.4%

Purpose

Diaper Rash Ointment

Skin Protectant

Uses

Helps prevent diaper rash. Temporarily protects minor cuts, scrapes and burns. Temporarily protects and helps relieve chapped, chafed or cracked skin. Helps protect chafed skin due to diaper rash and helps seal out wetness.

Warnings

For external use only.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask doctor if condition worsens or symptoms last more than 7 days. If swallowed, get medical help or contact a poison control center immediately.

Do not use on deep or puncture wounds, animal bites or serious burns.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Direction

Apply as needed to dry or irritated skin. If using for diaper changes, gently clean diaper area and allow to dry. Apply cream liberally with each diaper change and as often as desired.

Other Information

Store at 20°C to 25°C (68°F to 77°F). Do not use if seal under cap on tube is broken, missing or if tube tip is cut prior to opening. Store upright when not in use.

Inactive Ingredients

Cod liver oil (contains vitamin A&D), fragrance, light mineral oil, microcrystalline wax, paraffin

PRINCIPAL DISPLAY PANEL

label

VITAMIN A AND D 
lanolin and petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN15.5 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM53.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COD LIVER OIL (UNII: BBL281NWFG)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-103-01113 g in 1 TUBE; Type 0: Not a Combination Product11/08/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/08/2017
Labeler - Family Dollar Services Inc (024472631)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(55319-103)

Revised: 11/2017
Document Id: 5d7cc3fd-df87-38a2-e053-2a91aa0a69fb
Set id: 4826b36d-3326-4f5c-8b22-c5ff79e55062
Version: 1
Effective Time: 20171108
 
Family Dollar Services Inc