RUGBY ANTI-ITCH- camphor, menthol lotion 
RUGBY LABORATORIES

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.

----------

Rugby Original Anti-Itch Lotion

Active Ingredients

Camphor 0.5%............................................................................................................................ External analgesic

Menthol 0.5%.............................................................................................................................. External analgesic

Uses

temporary relieves pain and itching due to:

insect bites

minor burns

sunburn

minor skin irritations

minor cuts

scrapes

rashes due to poison ivy, poison oak, and poison sumac

dries the oozing and weeping of poison:

ivy

oak

sumac

Warning

For external use only

when using this product

do not get into eyes

Stop Use and ask doctor if

condition worsens

symptoms last 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.

Purpose

Anti - itch

Directions

to open, squeeze cap tightly and turn pump counter-clockwise

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

Other information

store at 20 °C to 25 °C (68 °F to 77 °F)

Inactive ingredients

carbomer 940, cetyl alcohol, DMDM hydantoin, fragrance, glyceryl stearate, isopropyl myristate, PEG-40 stearate,
PEG-100 stearate, purified water, sodium hydroxide, stearic acid, white petrolatum

Principal Display Panel

rugby .jpg

RUGBY ANTI-ITCH 
camphor, menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1268
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.5 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
WATER (UNII: 059QF0KO0R)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PEG-100 STEARATE (UNII: YD01N1999R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1268-12212 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/20/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/16/2019
Labeler - RUGBY LABORATORIES (079246066)
Registrant - Weeks & Leo Co., Inc. (005290028)
Establishment
NameAddressID/FEIBusiness Operations
Weeks & Leo005290028manufacture(0536-1268)

Revised: 12/2019
Document Id: 99d8a53f-8b88-033d-e053-2995a90ad4b0
Set id: 99d8ad9e-46ec-15fc-e053-2995a90a0d17
Version: 6
Effective Time: 20191213
 
RUGBY LABORATORIES