SPL v4
SPL
SPL Set ID 80d3031a-7fa9-4f5b-b85e-c7c6ef314801
Route
TOPICAL
Published
Effective Date 2022-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Histamine (0.00025 g)
Inactive Ingredients
Butylene Glycol C13-14 Isoparaffin Chondroitin Sulfate (shark) Emu Oil Ethylhexyl Stearate Glucosamine Hydrochloride Helianthus Annuus Flowering Top Laureth-7 Methylisothiazolinone Dimethyl Sulfone Polyacrylamide (1500 Mw) Potassium Sorbate Sodium Polyacrylate (8000 Mw) Tetrasodium Edetate Dihydrate .alpha.-tocopherol Acetate Trideceth-6 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-30

Description

Histamine Dihydrochloride  0.025% 

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Dosage and Administration

For use by adults and Children over 12 years of age.

apply a thin layer to the pain site and massage until thoroughly absorbed into skin. Apply no more than 3 to 4 times daily.

Children 12 years or younger consult a physician.

Description

Histamine Dihydrochloride  0.025% 

Uses

For temporary relief of minor aches and pains of muscles and joints assited with arthritis, simple backache, strains & bruises.

Section 50565-1

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

For external use only.

Do not use on wounds or damaged skin or if you are allergic to ingredients in the product.

Active Ingredient 

Histamine Dihydrochloride  0.025% 

Other Information 

Store between 68° and 77° F ( 20° and 25° C)

Tamper evident feature:do not use if outer shrink wrap on jar is torn, broken or missing.

Inactive Ingredients 

 Butylene Glycol, C13-C14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethylhexyl Stearate, Glucosamine HCL, Hellanthus Annuus( Sunflower )Oil, Laureth-7, Methylisothiazolinone, Methylsulfonylmethane,Polyacrylamide, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA,   Tocopheryl Acetate, Trideceth-6, Water (purified)

When Using This Product

Avoid contact with eyes. If product gets into eyes,rinse thoroughly with water.

Do not bandage tightly or use a heating pad.

Principal Display Panel Jar

Walgreens Arthritis Pain Relief    NDC 0363-5301-40

Histamine Dihydrochloride 0.025%

Arthritis Pain Relief Cream 

NET WT 4OZ (113g)

Stop Use and Ask A Doctor If

Rash appears.

Condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.


Structured Label Content

Uses

For temporary relief of minor aches and pains of muscles and joints assited with arthritis, simple backache, strains & bruises.

Dosage and Administration (34068-7)

For use by adults and Children over 12 years of age.

apply a thin layer to the pain site and massage until thoroughly absorbed into skin. Apply no more than 3 to 4 times daily.

Children 12 years or younger consult a physician.

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Topical Analgesic

Warnings

For external use only.

Do not use on wounds or damaged skin or if you are allergic to ingredients in the product.

Active Ingredient 

Histamine Dihydrochloride  0.025% 

Other Information 

Store between 68° and 77° F ( 20° and 25° C)

Tamper evident feature:do not use if outer shrink wrap on jar is torn, broken or missing.

Inactive Ingredients 

 Butylene Glycol, C13-C14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethylhexyl Stearate, Glucosamine HCL, Hellanthus Annuus( Sunflower )Oil, Laureth-7, Methylisothiazolinone, Methylsulfonylmethane,Polyacrylamide, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA,   Tocopheryl Acetate, Trideceth-6, Water (purified)

When Using This Product (When using this product)

Avoid contact with eyes. If product gets into eyes,rinse thoroughly with water.

Do not bandage tightly or use a heating pad.

Principal Display Panel Jar (Principal Display Panel -Jar)

Walgreens Arthritis Pain Relief    NDC 0363-5301-40

Histamine Dihydrochloride 0.025%

Arthritis Pain Relief Cream 

NET WT 4OZ (113g)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Rash appears.

Condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.


Advanced Ingredient Data


Raw Label Data

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