984 Activice Gel

984 Activice Gel
SPL v10
SPL
SPL Set ID 834adeb9-38ad-0cfe-e053-2991aa0af82f
Route
TOPICAL
Published
Effective Date 2023-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (80 mg)
Inactive Ingredients
Pentylene Glycol Water Peg-8 Dimethicone Trolamine Peppermint Alcohol Hydroxypropyl Cellulose (1600000 Wamw) Eucalyptus Oil Glucosamine Sulfate Dimethyl Sulfone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-04

Description

Menthol 8.0%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 8.0%

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.

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.

Package Label

Active Ingredient

Menthol 8.0%

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).

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
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

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.


Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

Topical Analgesic

Warnings

For external use only.

Avoid contact with eyes.

Flammable: keep away from fire or flame.

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.

Package Label

Active Ingredient (Active ingredient)

Menthol 8.0%

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (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).

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
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

Stop Use and Ask Doctor If (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, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)