Label: ELIZABETH HEALTH STYLE ICE COLD (camphor- synthetic, levomenthol gel
- NDC Code(s): 80591-002-01
- Packager: AYUSHREE PHARMACEUTICALS PRIVATE LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 28, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Use
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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 tightlyWhen 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
- Directions
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
ELIZABETH HEALTH STYLE ICE COLD
camphor (synthetic), levomenthol gelProduct 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)