ANTI ITCH- menthol lotion
Greenbrier International, 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.

----------

ANTI ITCH BODY LOTION

Drug Facts

Active Ingredient

Menthol 0.15%

Purpose
Anti Itch

Uses

for temporary relief of itch

Warnings

For external use only

For adult use only

Do not use on

deep or puncture wounds
animal bites
serious burns

When using this product avoid contact with eyes.

Stop use and ask a doctor if

condition worsens
redness, irritation, swelling or pain persists or increases
symptoms 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

apply freely to affected area 3 or 4 times daily

Other Information

Store at 20 degrees C - 25 degrees C (68 degrees to 77 degrees F)

Inactive Ingredients
water, glycerin, cetearyl alcohol, ammonium polyacrylate, mineral oil, glyceryl stearate, carbomer, dimethicone, triethanolamine, aloe barbadensis leaf extract, tocopheryl acetate, methylisothiazolinone.

DISTRIBUTED BY:

GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320
MADE IN CHINA

PACKAGELABEL

fda1

ANTI ITCH
menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:33992-8816
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
CARBOMER 940 (UNII: 4Q93RCW27E)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHANOLAMINE LAURATE (UNII: 9403LC9W1J)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHERYL RETINOATE (UNII: 0WN694NBMM)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:33992-8816-1	142 g in 1 TUBE; Type 0: Not a Combination Product	09/15/2014	03/31/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/15/2014	03/31/2017

Labeler - Greenbrier International, Inc. (610322518)

Name	Address	ID/FEI	Business Operations
Establishment
Lab Douce Cosmetics (Shenzhen) Co., Ltd.		529303186	manufacture(33992-8816)

Revised: 3/2018

Document Id: 6acd750a-23fa-5e99-e053-2a91aa0a708e

Set id: bb012128-7f63-41fe-82b3-cf16335d8af6

Version: 3

Effective Time: 20180331

Greenbrier International, Inc.