992 Activice Roll-on

992 Activice Roll-on
SPL v6
SPL
SPL Set ID 8465b443-abe9-78fb-e053-2a91aa0ac1d8
Route
TOPICAL
Published
Effective Date 2023-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (80 g)
Inactive Ingredients
Carbomer 940 Alcohol Glucosamine Sulfate Trolamine Glycerin Boswellia Serrata Resin Oil Dimethyl Sulfone Peppermint Water Eucalyptus Oil

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:

roll 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.

Package Labels

Active Ingredient

Menthol 8.0%

Other Information
  • Store at room temperature.
Inactive Ingredients

boswellia serrata extract, carbomer,

dimethylsulfone(MSM), eucalyptus oil,

glucosamine sulfate, glycerin,

peppermint oil, SD alcohol 39C,

triethanolamine, water.

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: MDSAICEROLL, V4 RH23MFO

REF: MDSAICEROLLR, V3 RJ21MFO

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
  • excessiveirritation of the skin develops
If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help 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:

roll 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.

Package Labels

Active Ingredient

Menthol 8.0%

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

boswellia serrata extract, carbomer,

dimethylsulfone(MSM), eucalyptus oil,

glucosamine sulfate, glycerin,

peppermint oil, SD alcohol 39C,

triethanolamine, water.

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: MDSAICEROLL, V4 RH23MFO

REF: MDSAICEROLLR, V3 RJ21MFO

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
  • excessiveirritation 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 help or contact

a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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