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

Purpose

Topical Analgesic

Description

Menthol 8.0%


Medication Information

Warnings

For external use only.

Avoid contact with eyes.

Flammable: keep away from fire

or flame.

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

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.

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.

Description

Menthol 8.0%

Package Labels

Active Ingredient

Menthol 8.0%

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

Warnings

For external use only.

Avoid contact with eyes.

Flammable: keep away from fire

or flame.

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

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.

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.

Package Labels

Active Ingredient

Menthol 8.0%

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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