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NDC 00536-1268-12 Rugby Anti-Itch .5; .5 g/100g; g/100g Details

Rugby Anti-Itch .5; .5 g/100g; g/100g

Rugby Anti-Itch is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by RUGBY LABORATORIES. The primary component is CAMPHOR (SYNTHETIC); MENTHOL.

Product Information

NDC	00536-1268
Product ID	0536-1268_99d8a53f-8b88-033d-e053-2995a90ad4b0
Associated GPIs	90229902104120
GCN Sequence Number	023766
GCN Sequence Number Description	menthol/camphor LOTION 0.5 %-0.5% TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	79831
HICL Sequence Number	002600
HICL Sequence Number Description	MENTHOL/CAMPHOR
Brand/Generic	Generic
Proprietary Name	Rugby Anti-Itch
Proprietary Name Suffix	n/a
Non-Proprietary Name	Camphor, Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	.5; .5
Active Ingredient Units	g/100g; g/100g
Substance Name	CAMPHOR (SYNTHETIC); MENTHOL
Labeler Name	RUGBY LABORATORIES
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00536-1268-12 (00536126812)

Pricing Information
NDC Package Code	0536-1268-12
Billing NDC	00536126812
Package	212 g in 1 BOTTLE, PUMP (0536-1268-12)
Marketing Start Date	2019-12-20
NDC Exclude Flag	N
Price Per Unit	0.01969
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	ANTI-ITCH 0.5%-0.5% LOTION
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 99d8ad9e-46ec-15fc-e053-2995a90a0d17 Details

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

INGREDIENTS AND APPEARANCE

RUGBY ANTI-ITCH

camphor, menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-1268
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.5 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-1268-12	212 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/20/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/16/2019

Labeler - RUGBY LABORATORIES (079246066)

Registrant - Weeks & Leo Co., Inc. (005290028)

Name	Address	ID/FEI	Business Operations
Establishment
Weeks & Leo		005290028	manufacture(0536-1268)

Revised: 12/2019

Document Id: 99d8a53f-8b88-033d-e053-2995a90ad4b0

Set id: 99d8ad9e-46ec-15fc-e053-2995a90a0d17

Version: 6

Effective Time: 20191213