ELIZABETH HEALTH STYLE ICE COLD by AYUSHREE PHARMACEUTICALS PRIVATE LIMITED

ELIZABETH HEALTH STYLE ICE COLD by

Drug Labeling and Warnings

ELIZABETH HEALTH STYLE ICE COLD by is a Otc medication manufactured, distributed, or labeled by AYUSHREE PHARMACEUTICALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ELIZABETH HEALTH STYLE ICE COLD- camphor (synthetic), levomenthol gel 
AYUSHREE PHARMACEUTICALS PRIVATE LIMITED

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 Ingredient                            Purpose

Menthol 2.50% .......................... Topical analgesic

Camphor 0.5 % ......................... Topical analgesic

Use

for the temporary relief of minor aches and pains in muscle and joints associated with:
simple backache strains sprains
sports injuries arthritis bruises

Warnings

For external use only
Do not use with other topical pain relievers with heating pads or heating devices.

When using this product
do not use in or near eyes
do not apply to wounds or damaged skin
do not bandage tightly

When using this product

• do not use in or near eyes
• do not apply to wounds or damaged skin
• do not bandage tightly

Stop use and ask doctor if

• Conditions worsens symptoms last more than 7 days or clear up and occur again within a few days
• redness or irritation develop

If pregnant or breast-feeding, ask a heath professional before use

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• clean affected area before applying product

      adults and children 2 year of age and older: apply to affected area

• not more than 3 to 4 times daily.

Inactive ingredients

Carbomer 940, Color: FD&C Blue No.1, lsopropyl Alcohol, Methyl Chloroisothiazolinone, Methyl lsothiazolinone, Propylene Glycol, Purified Water, Triethanolamine.

Questions? ca11 305-627-3116

Package Label - Principal Display Panel

ELIZABETH HEALTH STYLE ICE COLD 
camphor (synthetic), levomenthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80591-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	2.5 g  in 100 g
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80591-002-01	227 g in 1 DRUM; Type 0: Not a Combination Product	09/28/2020	02/28/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/28/2020	02/28/2024

Labeler - AYUSHREE PHARMACEUTICALS PRIVATE LIMITED (861375952)

Establishment
Name	Address	ID/FEI	Business Operations
AYUSHREE PHARMACEUTICALS PRIVATE LIMITED		861375952	manufacture(80591-002)

Revised: 7/2021

Document Id: c836cc9a-9803-2b1f-e053-2995a90ae3a6

34390-5

Set id: 83e784ad-7858-4e08-b590-186b718d41cf

Version: 3

Effective Time: 20210728