BUDPAK VITAMIN A AND D- vitamin a and d cream

Budpak Vitamin A and D by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Vitamin A  181.8 IU

Vitamin D   1200 IU

PURPOSE

Purpose

Skin protectant

INDICATIONS & USAGE

Uses

• helps prevent diaper rash
• heals dry, flaky and chafed skin
• soothes and protects minor cuts and burns

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use in eyes

• not for extensive burns or serious cuts, consult a physician

STOP USE

Stop use and ask a doctor if redness, irritation, swelling or pain persists or increases or if infection develops.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

• Apply generously and massage until absorbed. Repeat as necessary.

SPL UNCLASSIFIED SECTION

Other information

• Store at controlled room temperature 15ºC to 30ºC (59ºF to 86ºF). Lot No. & Exp.Date see crimp of tube.

INACTIVE INGREDIENT

Inactive ingredients

Cetyl Alcohol, DMDM Hydantoin, Glyceryl Monostearate, Methylparaben, Mineral Oil, Polysorbate 20, Propylparaben, Stearic Acid,  Trisodium EDTA, and Water.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Budpak Vitamin A&D Cream

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

BUDPAK VITAMIN A AND D 
vitamin a and d cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-036
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	181.8 [iU]  in 1 g
VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41)	VITAMIN D	1200 [iU]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27293-036-28	28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	04/01/2015

Labeler - Budpak Inc. (183224849)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(27293-036)