Body by Major Pharmaceuticals / Vi-Jon / MK Packaging Drug Facts

Body by

Drug Labeling and Warnings

Body by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Vi-Jon, MK Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BODY- menthol, zinc oxide powder 
Major Pharmaceuticals

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

Menthol 0.15%

Zinc oxide 1.0%

Purpose

External analgesic

Skin protectant

Uses

for temporary relief of pan and itching due to:

  • mnor cuts
  • sunburn
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • scrapes 
  • minor burns
  • minor skin irritations

dries the oozing and weeping of:

  • poison ivey
  • poison oak
  • poison sumac

warnings

For external use only

When using this product

avoid contact with the eyes

Stop use and ask a doctor

If condition worsens, or if symtpoms persist for more than 7 days or clear up and occur again within a few days

keep out of reach of children

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

Directions

adults and children 2 year of age and older - apply to affected area not more than 3 to 4 times daily

children under 2 years of age - do not use, consult a doctor

  • for best results dry skin thoroughly before applying

Inactive ingredients

talc, acacia, eucaluptol, methyl salicylate, salicylic acid, thymol, zinc stearate

disclaimers

This product is sold by weight, not by volume.  

Major Medicated Body powder is not manufactured or distributed by Chattem, Inc., distributor of Gold Bond Medicated Body Powder

Adverse Reaction

Distributed By

MAJOR PHARMACEUTICALS

31778 ENTERP0RISE DRIVE

LIVONIA, MI 48150 USA

SERIOUS SIDE EFFECTS ASSOCAITED WITH USE OF THIS  PRODUCT MAY BE REPORTED TO: 1-800-616-2471

PRINCIPAL DISPLAY PANEL

NDC: 0904-5098-77

MAJOR

MEDICATED

BODY

POWDER

WITH ESSENTIAL OILS

Compare to Active Ingredients of Gold Bond Medicated Body Powder

Relieves Pain + Itch

Soothes + Protects Skin

Absorbs Moisture

Skin Protectant/External Analgesic

Net Wt 10 oz (283 g)

image description
BODY 
menthol, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0904-5098
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1.5 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
ACACIA (UNII: 5C5403N26O)  
EUCALYPTOL (UNII: RV6J6604TK)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
THYMOL (UNII: 3J50XA376E)  
ZINC STEARATE (UNII: H92E6QA4FV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0904-5098-77283 g in 1 BOTTLE; Type 0: Not a Combination Product08/21/200301/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/21/200301/29/2019
Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2020
Document Id: 5df80673-72ff-49f6-b343-769e68c18542
Set id: edb6878d-1caf-4c4a-b3b9-1c4d053e60ac
Version: 2
Effective Time: 20200102
 
Major Pharmaceuticals