LUCKY BLUE ICE - menthol and camphor (synthetic) gel
Delta Brands 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.

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Active Ingredients
Menthol 1.0%
Camphor 0.5%

Purpose
Topical Analgesic

Use
Lucky Super Soft Blue Ice Gel to provide temporary relief of minor pains and aches in your body's joints and muscles associated with:

sports injuries
sprains
arthritis
bruises

Warnings for external use only
Do not apply to wound or damaged skin. Do not bandage the applied surface.
If condition worsens, discontinue use of this product.
Consult a physician if symptoms persist for more than 7 days. Avoid contact with mucus membranes and eyes. Do not use with heating devices or pads.

Keep Out of Reach of Children.

If Pregnant or breast feeding, ask a health professional before use

Directions Apply liberally to painful zones and massage until absorbed into the skin. Repeat daily 3 or 4 times. Keep out of reach of children. Do not apply to children below two years of age.

Inactive Ingredients De-ionized water, Isopropyl Alcohol, Propylene Glycol,
Carbopol, PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide,
Disodium EDTA, Benzyl Alcohol, BHT, FDC Blue No. 1

Package Label Principal Display Panel

image of package label

LUCKY BLUE ICE
menthol camphor gel

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:20276-210
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Menthol (Menthol)	Menthol	1 g in 100 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC))	CAMPHOR (SYNTHETIC)	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL
BENZYL ALCOHOL
BUTYLATED HYDROXYTOLUENE
CARBOMER 934
EDETATE DISODIUM
FD&C BLUE NO. 1
HYDROGENATED CASTOR OIL
ISOPROPYL ALCOHOL
POLYETHYLENE GLYCOL 200
SODIUM HYDROXIDE
WATER

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:20276-210-08	227 g in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	11/15/2009

Labeler - Delta Brands Inc (102672008)

Name	Address	ID/FEI	Business Operations
Establishment
Anicare Pharmaceuticals Pvt Ltd		916837425	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Ningbo Pulisi Daily Chemical Products Co., Ltd.		529047265	manufacture

Revised: 6/2012

Document Id: 896401c3-c0c0-44d1-bce4-6553328f1026

Set id: 5d3060a3-389e-46bf-a2a8-23873df9f017

Version: 2

Effective Time: 20120628

Delta Brands Inc