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NDC 46122-0573-10 GNP Anti Itch .5; .5 g/100g; g/100g Details

GNP Anti Itch .5; .5 g/100g; g/100g

GNP Anti Itch is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by AMERISOURCEBERGEN DRUG CORPORATION. The primary component is CAMPHOR (SYNTHETIC); MENTHOL.

Product Information

NDC	46122-0573
Product ID	46122-573_b4f2d6f7-2288-47d8-e053-2995a90ae335
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	GNP 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	AMERISOURCEBERGEN DRUG CORPORATION
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 46122-0573-10 (46122057310)

Pricing Information
NDC Package Code	46122-573-10
Billing NDC	46122057310
Package	212 g in 1 BOTTLE, PUMP (46122-573-10)
Marketing Start Date	2020-11-25
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 b4f2d6f7-2287-47d8-e053-2995a90ae335 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

Warning

For external use only

Ask doctor before use

on chicken pox

on measles

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

Original Formula Anti-Itch Lotion

Camphor 0.5%

Menthol 0.5%

Steroid Free

Relief from itching associated with dry skin, insectr bites, poison ivy and Sunburn

Cools and Soothes

INGREDIENTS AND APPEARANCE

GNP ANTI ITCH

camphor, menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46122-573
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
PEG-40 STEARATE (UNII: ECU18C66Q7)
STEARIC ACID (UNII: 4ELV7Z65AP)
CARBOMER 940 (UNII: 4Q93RCW27E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:46122-573-10	212 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/25/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	11/25/2020

Labeler - AMERISOURCEBERGEN DRUG CORPORATION (007914906)

Name	Address	ID/FEI	Business Operations
Establishment
Weeks & Leo		005290028	manufacture(46122-573)

Revised: 11/2020

Document Id: b4f2d6f7-2288-47d8-e053-2995a90ae335

Set id: b4f2d6f7-2287-47d8-e053-2995a90ae335

Version: 1

Effective Time: 20201125