BUDPAK VITAMIN A AND D- vitamin a and d cream 
Budpak 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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Budpak Vitamin A&D Cream

Active Ingredients

Vitamin A  181.8 IU

Vitamin D   1200 IU

Purpose

Skin protectant

Uses

Warnings

For external use only

Do not use in eyes

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.

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

Directions

Other information

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

Budpak Vitamin A&D Cream

NET WT 1 OZ (28 g)

image of package label

BUDPAK VITAMIN A AND D 
vitamin a and d cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-036
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A181.8 [iU]  in 1 g
VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41) VITAMIN D1200 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27293-036-2828 g in 1 TUBE; Type 0: Not a Combination Product02/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34704/01/2015
Labeler - Budpak Inc. (183224849)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-036)

Revised: 1/2022
Document Id: d6dd851c-0ff2-2d19-e053-2a95a90abaf6
Set id: 373c4976-9886-438b-8eef-db1eaa556faf
Version: 2
Effective Time: 20220131
 
Budpak Inc.