Label: ICE COLD ANALGESIC- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 58503-087-01 - Packager: China Ningbo Shangge Cosmetic Technology Corp.
- 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 10, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Directions
For the temporary relief of minor muscle aches and pains.
See important warnings under "When using this product"
- not for use on children under 2 years of age
- adults & children 2 years & older: apply liberally to painful area and massage until gel is absorbed into the skin. Repeat 3 to 4 times daily.
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WARNINGS
Warnings
For external use only; avoid contact with eyes.
Ask a doctor before use if you have cough associated with
- smoking
- excessive phlegm
- asthma
- emphysema
- persistent or chronic cough
When using this product,do not:
- heat
- microwave
- add to hot water or any container where healing water may cause splattering and result in burns
- use in eyes or directly on mucous membranes
- take my mouth or place in nostrils
- apply to wounds or damaged skin
- bandage skin
Consult a doctor and discontinue use: if condition worsens, persists for more than 1 week or tends to recur.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ICE COLD ANALGESIC
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-087 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g Inactive Ingredients Ingredient Name Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ISOPROPYL ALCOHOL (UNII: ND2M416302) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58503-087-01 227 g in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/10/2015 Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434) Establishment Name Address ID/FEI Business Operations Volume Distributors, Inc. 002029544 manufacture(58503-087)
