ActivICE by Medline Industries, LP ACTIVICE- menthol spray

ActivICE by

Drug Labeling and Warnings

ActivICE by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 10.0%

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 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 our of reach of children.

If swallowed, get medical help 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

boswellia serrata extract, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerine, SD alcohol 39C, PEG-8 dimethicone, pentylene glycol, peppermint oil, water (USP)

Manufacturing information

REF: MDSAICESPRY4

Not made with Natural Rubber Latex.

www.medline.com Manufactured in USA for: Medline Industries, Inc.

Three Lakes Drive, Northfield, IL 60093 1-800MEDLINE

*This product is not manufactured or distributed by Performance Health and/or its subsidiaries, owner of the registered trademark Biofreeze®.

Package Label

INGREDIENTS AND APPEARANCE

ACTIVICE 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-996
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PEPPERMINT OIL (UNII: AV092KU4JH)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
ALCOHOL (UNII: 3K9958V90M)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
WATER (UNII: 059QF0KO0R)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-996-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2020

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Troy Manufacturing, Inc.		160075248	manufacture(53329-996)