VITAMIN A AND D- lanolin and petrolatum ointment

Vitamin A and D by

Drug Labeling and Warnings

Vitamin A and D by is a Otc medication manufactured, distributed, or labeled by Family Dollar Services Inc, Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Lanolin         15.5%

Petrolatum   53.4%

PURPOSE

Purpose

Diaper Rash Ointment

Skin Protectant

INDICATIONS & USAGE

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

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).

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

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 INGREDIENT

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VITAMIN A AND D 
lanolin and petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	15.5 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	53.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COD LIVER OIL (UNII: BBL281NWFG)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-103-01	113 g in 1 TUBE; Type 0: Not a Combination Product	11/08/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/08/2017

Labeler - Family Dollar Services Inc (024472631)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(55319-103)