australian dream power 4 muscle & joint pain relief cream

australian dream power 4 muscle & joint pain relief cream
SPL v1
SPL
SPL Set ID 2c3e3a3c-d7f1-4893-9080-849fcf0f04e5
Route
topical
Published
Effective Date 2023-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (0.10 g) menthol (0.03 g) camphor (synthetic) (0.025 g) capsaicin
Inactive Ingredients
water carbomer copolymer type a tocopherol cetostearyl alcohol polysorbate 60 stearic acid emu oil glycerin phenoxyethanol caprylyl glycol yucca schidigera root aloe vera leaf sodium carbonate

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2023-05-10

Purpose

Topical Analgesic

Description

Camphor 3%, Capsaicin 0.025%, Methyl Salicylate 10%, Menthol 3%


Medication Information

Warnings

For external use only. Allery Alert: If prone to allergic reaction from asprin or salicylates, capsisum or chili peppers, or any ingredients in this product, consult a doctor before use. ​Do not use ​on wounds or damaged, broken, or irritated skin, at the same time as other topical analgesics. ​When using this product​, use only as directed. ​Read and follow all directions and warning on this label. Aviod contact with eyes and mucous membranes. If contact is made, rinse thoroughly with water. Rare cases of serious burns have been reported with this type of product. Avoid applying into skin folds. Discontinue use at leat 1 hour before a bath, shower, swim, or sweating. Do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use. A transient burning sensation may occur upon application but generlly disappears in several days. If severe burning sensation occurs, discontinue use immediately. Do notexpoes the area treated with product to heat or direct sunlight. ​Stop use and ask a doctor if, ​rash, redness or irritation appears, condition worsens, symtoms persist for more than 7 days or clear up and occur again within a few days. ​If pregnant or breast-feeding, ​ask a health care professional before use. 

Uses

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

Purpose

Topical Analgesic

Directions

​For use by adults 18 years of age and older. ​Apply a thin layer to affected area not more than 3 to 4 times daily. Wash hands with soap or dishwashing liquid after application. If using on hands, allow 30 minutes for absorption before washing hands. Massage intopainful area until thoroughly absorbed into skin. ​Children under 18 years consult a physician. ​Store between 40F and 86F (4C and 30C), Tamper Evident Feature: do not use if outer shrink wrap on jar is torn, broken or missing.

Inactive Ingredients

Aloe Barbadensis (Aloe Vera) Leaf Juice, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Emu Oil, Glycerin, Phenoxyethanol, Polysorbate 60, Purifed Water, Sodium Carbonate, Stearic Acid, Tocopheryl Acetate, Yucca Schidigera Root Extract.

Description

Camphor 3%, Capsaicin 0.025%, Methyl Salicylate 10%, Menthol 3%

Section 51945-4

Active Ingredients

Camphor 3%, Capsaicin 0.025%, Methyl Salicylate 10%, Menthol 3%

Questions Or Comments?

Call 1-888-600-4642

Keep Out of Reach of Children and Pets.

If swallowed, get medical help or contact a Poison Control Center right away


Structured Label Content

Warnings

For external use only. Allery Alert: If prone to allergic reaction from asprin or salicylates, capsisum or chili peppers, or any ingredients in this product, consult a doctor before use. ​Do not use ​on wounds or damaged, broken, or irritated skin, at the same time as other topical analgesics. ​When using this product​, use only as directed. ​Read and follow all directions and warning on this label. Aviod contact with eyes and mucous membranes. If contact is made, rinse thoroughly with water. Rare cases of serious burns have been reported with this type of product. Avoid applying into skin folds. Discontinue use at leat 1 hour before a bath, shower, swim, or sweating. Do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use. A transient burning sensation may occur upon application but generlly disappears in several days. If severe burning sensation occurs, discontinue use immediately. Do notexpoes the area treated with product to heat or direct sunlight. ​Stop use and ask a doctor if, ​rash, redness or irritation appears, condition worsens, symtoms persist for more than 7 days or clear up and occur again within a few days. ​If pregnant or breast-feeding, ​ask a health care professional before use. 

Uses

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

Purpose (PURPOSE)

Topical Analgesic

Directions

​For use by adults 18 years of age and older. ​Apply a thin layer to affected area not more than 3 to 4 times daily. Wash hands with soap or dishwashing liquid after application. If using on hands, allow 30 minutes for absorption before washing hands. Massage intopainful area until thoroughly absorbed into skin. ​Children under 18 years consult a physician. ​Store between 40F and 86F (4C and 30C), Tamper Evident Feature: do not use if outer shrink wrap on jar is torn, broken or missing.

Inactive Ingredients

Aloe Barbadensis (Aloe Vera) Leaf Juice, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Emu Oil, Glycerin, Phenoxyethanol, Polysorbate 60, Purifed Water, Sodium Carbonate, Stearic Acid, Tocopheryl Acetate, Yucca Schidigera Root Extract.

Section 51945-4 (51945-4)

Active Ingredients

Camphor 3%, Capsaicin 0.025%, Methyl Salicylate 10%, Menthol 3%

Questions Or Comments? (Questions or Comments?)

Call 1-888-600-4642

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

If swallowed, get medical help or contact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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