GOLD BOND MEDICATED ORIGINAL STRENGTH BODY- menthol powder 
Navajo Manufacturing Company 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.

----------

Gold Bond Medicated Original Strength Body Powder - Reformulated

Gold Bond Medicated

Original Strength Body Powder

Drug Facts

Active ingredient

Menthol 0.15%

Purpose

Anti-itch

Uses

temporarily relieves the pain and itch associated with:

■ minor cuts ■ sunburn ■ insect bites ■ scrapes ■ minor burns ■ minor skin irritations

Warnings

For external use only

When using this product

■ avoid contact with eyes

Stop use and ask a doctor if

■ condition worsens

■ symptoms persist for more than 7 days or clear up and occur again within a few days

■ redness, irritation, swelling or pain persists or increases

Keep out of reach of children.

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

Directions

■  adults and children 2 years and older: apply freely up to 3 or 4 times daily  

■  children under 2 years: ask a doctor

■ for best results dry skin thoroughly before applying

Inactive ingredients

zea mays (corn) starch, zinc oxide, acacia senegal gum, silica, tricalcium phosphate, eucalyptol, methyl salicylate, salicylic acid, zinc stearate, thymol

PRINCIPAL DISPLAY PANEL

Gold Bond

GOLD BOND MEDICATED ORIGINAL STRENGTH BODY 
menthol powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-225(NDC:41167-0110)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
ACACIA (UNII: 5C5403N26O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
EUCALYPTOL (UNII: RV6J6604TK)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
ZINC STEARATE (UNII: H92E6QA4FV)  
THYMOL (UNII: 3J50XA376E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67751-225-011 in 1 BLISTER PACK03/01/2021
128 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2021
Labeler - Navajo Manufacturing Company Inc. (091917799)
Establishment
NameAddressID/FEIBusiness Operations
Navajo Manufacturing Company Inc.136941411relabel(67751-225) , repack(67751-225)

Revised: 3/2023
Document Id: f71d4eea-ec9f-d274-e053-6394a90a24e8
Set id: f71d598c-92c3-d6fd-e053-6394a90a97d7
Version: 1
Effective Time: 20230317
 
Navajo Manufacturing Company Inc.