ActivICE spray

ActivICE spray

Drug Labeling and Warnings

Drug Details

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ACTIVICE- menthol spray 
Medline Industries

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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ActivICE spray

Active Ingredient

Menthol 8.0%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only.

Avoid contact with eyes.

Flammable: keep away from fire or flame.

Do not puncture or incinerate. Contents under pressure.

When using this product

  • use only as directed
  • do not bandage tightly or use with heating pad
  • do not apply to wounds or damaged skin

Stop use and ask a doctor if

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • excessive irritation of the skin develops

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical helop or contact a Poison Control Center right away.

Directions

Adults and children over 12 years:

  • spray directly onto affected area without the need to rub, massage or bandage
  • repeat if necessary, but do not apply more than 4 times daily.

Children 12 years or younger: ask a doctor.

Other Information

  • Store at room temperature.

Inactive Ingredients

citric acid, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, peppermint oil, SD alcohol 39C, water.

4 oz.

ACTIVICE 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53329-991
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL80 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ALCOHOL (UNII: 3K9958V90M)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53329-991-04113.4 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/04/2019
Labeler - Medline Industries (025460908)
Establishment
NameAddressID/FEIBusiness Operations
Troy Manufacturing160075248manufacture(53329-991)

Revised: 3/2019
 
Medline Industries


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