ACTIVICE- menthol gel 
Medline Industries, LP

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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984 ActivIce gel

Active ingredient

Menthol 8.0%

Purpose

Topical Analgesic

Uses

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

Warnings

For external use only.

Avoid contact with eyes.

Flammable: keep away from fire or flame.

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 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:

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

Children 12 years or younger:

ask a doctor.

Other information

Inactive ingredients

acrylic acid/vinyl ester copolymer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, hydroxypropylcellulose, SD alcohol 39C, PEG-8 dimethicone, pentylene glycol, peppermint oil, triethanolamine, water (USP).

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: MDSAICEGEL, MDSAICEGELR

V3 RF23MFO, V4 RC22MFO

Package Label

Label V3 RF23MFO

PDP2

ACTIVICE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-984
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
WATER (UNII: 059QF0KO0R)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
TROLAMINE (UNII: 9O3K93S3TK)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ALCOHOL (UNII: 3K9958V90M)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-984-04118 mL in 1 TUBE; Type 0: Not a Combination Product03/04/2019
2NDC:53329-984-23946 mL in 1 BOTTLE; Type 0: Not a Combination Product03/04/2019
3NDC:53329-984-253785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/04/2019
4NDC:53329-984-30100 in 1 BOX03/04/2019
45.6 mL in 1 PACKET; Type 0: Not a Combination Product
5NDC:53329-984-06473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/04/2019
6NDC:53329-984-165.6 mL in 1 PACKET; 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, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 8/2023
Document Id: 039c2aad-a89a-a936-e063-6394a90ac53e
Set id: 834adeb9-38ad-0cfe-e053-2991aa0af82f
Version: 9
Effective Time: 20230823
 
Medline Industries, LP