Analgesic Gel

Analgesic Gel
SPL v2
SPL
SPL Set ID 5a9109e6-1ebb-4891-934f-e4008cd2f636
Route
TOPICAL
Published
Effective Date 2012-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4.54 g)
Inactive Ingredients
Water Isopropyl Alcohol Camphor (synthetic) Carbomer 934 Sodium Hydroxide Methylisothiazolinone Fd&c Blue No. 1 Nonoxynol-10

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-09-21

Description

Menthol 2%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 2%

Uses

For temporary relief of minor aches and muscles pain: simple back aches, sprains and strains common to sports activities, joint pains associated with arthritis.

Section 42229-5

For external use only. If swallowed contact a physician or poison control center immediately. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free of any creams ointments, sprays or liniments. Do not cover with bandage.

Section 51945-4

PRINCIPAL DISPLAY PANEL

elizabeth style

Therapeutic, Greaseless

Fast, temporary relief from minor aches and pains

Blue Ice

Net Wt. 8 Oz (227 g)

PAIN RELIEVING ANALGESIC GEL

Warnings

Use only as directed.

Directions

Clean skin of all other lotions, creams, ointments, liniments: Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times within a 24 hour period. No protective cover needed. Do not apply to children under 2 years of age.

Do Not Use

with heating pads or heating devices.

Discontinue use and consult a physician if skin irritation develops, condition recurs, worsens or symptoms persist for more that 7 days. Consult your doctor before use if you are pregnant or nursing. Do not use, pour, spill or store near heat or open flame. Store in a cool, dry place. Keep lid tightly closed.

Active Ingredients

Menthol 2%

Inactive ingredients

Water, Isopropyl Alcohol, Nonoxynol-10, Camphor, Carbomer, Sodium Hydroxide, Methylchloroisothiazolinone & Mathylisothiazolinone, FD&C Blue #1.


Structured Label Content

Uses

For temporary relief of minor aches and muscles pain: simple back aches, sprains and strains common to sports activities, joint pains associated with arthritis.

Section 42229-5 (42229-5)

For external use only. If swallowed contact a physician or poison control center immediately. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free of any creams ointments, sprays or liniments. Do not cover with bandage.

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

elizabeth style

Therapeutic, Greaseless

Fast, temporary relief from minor aches and pains

Blue Ice

Net Wt. 8 Oz (227 g)

PAIN RELIEVING ANALGESIC GEL

Purpose

Topical Analgesic

Warnings

Use only as directed.

Directions

Clean skin of all other lotions, creams, ointments, liniments: Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times within a 24 hour period. No protective cover needed. Do not apply to children under 2 years of age.

Do Not Use (Do not use)

with heating pads or heating devices.

Discontinue use and consult a physician if skin irritation develops, condition recurs, worsens or symptoms persist for more that 7 days. Consult your doctor before use if you are pregnant or nursing. Do not use, pour, spill or store near heat or open flame. Store in a cool, dry place. Keep lid tightly closed.

Active Ingredients

Menthol 2%

Inactive ingredients (Inactive Ingredients)

Water, Isopropyl Alcohol, Nonoxynol-10, Camphor, Carbomer, Sodium Hydroxide, Methylchloroisothiazolinone & Mathylisothiazolinone, FD&C Blue #1.


Advanced Ingredient Data


Raw Label Data

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