Atopalm Pain Relieving Cream

Atopalm Pain Relieving Cream
SPL v2
SPL
SPL Set ID 37af7fb3-d308-44ca-9bff-05d9a2a6ca14
Route
TOPICAL
Published
Effective Date 2012-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 g)
Inactive Ingredients
Water Glycerin Cetyl Alcohol Polysorbate 60 Glyceryl Monostearate Stearic Acid Dimethicone Isopropyl Myristate Myristoyl/palmitoyl Oxostearamide/arachamide Mea Trolamine Cholesterol Aloe Vera Leaf Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-08-14

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings For external use only.

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis like conditions

Indications and Usage

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Dosage and Administration
Directions



adults and children 12 years of age and older

apply to affected area not more than 3 to 4 times daily



Children under 12 years of age

ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other Information

store at 20 - 25 degrees Celsius (68 - 75 degrees Fahrenheit)

see carton or flap or tube crimp for  lot number and expiration date

Section 50565-1

Keep out of reach of children. If swallowed, get medical help immediately or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • conditions worsen

  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs
  • have redness over the affected area.

Section 50567-7

When using this product avoid contact with eyes or mucous membranes, do not bandage tightly.

Section 51727-6

Inactive Ingredients

WATER, GLYCERIN, CETYL ALCOHOL, POLYSORBATE 60, GLYCERYL STEARATE, STEARIC ACID, DIMETHICONE, ISOPROPYL MYRISTATE, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA, CARBOMER, TRIETHANOLAMINE, CHOLESTEROL, ALOE VERA GEL, METHYLPARABEN, PROPYLPARABEN.

Section 51945-4

Pain Relieving Cream

Non-Greasy, Non-Staining

10% Menthol

Ultra-light Nighttime Scent

DEEP PENETRATING PAIN RELIEF

ATOPALM (TM)

Developed for Nighttime Use

Goes on smoothly and leaves skin feeling soft and smooth

Net. Wt. 2 oz/57 g

Specially Formulated with US Patented MLE Technology



Section 53413-1

Questions or information call toll free: 1-855-ATOPALM

Section 55105-1

Purpose

Topical Analgesic

Section 55106-9

Active ingredient

Menthol 10%


Structured Label Content

Indications and Usage (34067-9)

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Dosage and Administration (34068-7)
Directions



adults and children 12 years of age and older

apply to affected area not more than 3 to 4 times daily



Children under 12 years of age

ask a doctor

Warnings and Precautions (34071-1)

Warnings For external use only.

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis like conditions

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other Information

store at 20 - 25 degrees Celsius (68 - 75 degrees Fahrenheit)

see carton or flap or tube crimp for  lot number and expiration date

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help immediately or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • conditions worsen

  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs
  • have redness over the affected area.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes or mucous membranes, do not bandage tightly.

Section 51727-6 (51727-6)

Inactive Ingredients

WATER, GLYCERIN, CETYL ALCOHOL, POLYSORBATE 60, GLYCERYL STEARATE, STEARIC ACID, DIMETHICONE, ISOPROPYL MYRISTATE, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA, CARBOMER, TRIETHANOLAMINE, CHOLESTEROL, ALOE VERA GEL, METHYLPARABEN, PROPYLPARABEN.

Section 51945-4 (51945-4)

Pain Relieving Cream

Non-Greasy, Non-Staining

10% Menthol

Ultra-light Nighttime Scent

DEEP PENETRATING PAIN RELIEF

ATOPALM (TM)

Developed for Nighttime Use

Goes on smoothly and leaves skin feeling soft and smooth

Net. Wt. 2 oz/57 g

Specially Formulated with US Patented MLE Technology



Section 53413-1 (53413-1)

Questions or information call toll free: 1-855-ATOPALM

Section 55105-1 (55105-1)

Purpose

Topical Analgesic

Section 55106-9 (55106-9)

Active ingredient

Menthol 10%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)