ActivICE by Medline Industries, LP ACTIVICE- menthol gel

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 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.

When using this product

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

• Store at room temperature.

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).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACTIVICE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-984
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	80 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-984-04	113.4 g in 1 TUBE; Type 0: Not a Combination Product	03/04/2019
2	NDC: 53329-984-23	907.185 g in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2019
3	NDC: 53329-984-25	3628.74 g in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2019
4	NDC: 53329-984-16	85 g in 1 PACKET; Type 0: Not a Combination Product	03/04/2019
5	NDC: 53329-984-06	453.59 g in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/04/2019

Labeler - Medline Industries (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Troy Manufacturing, Inc.		160075248	manufacture(53329-984)