Pain Cream

Pain Cream
SPL v2
SPL
SPL Set ID 17dff3c1-3c0b-16f6-e063-6394a90a3c05
Route
TOPICAL
Published
Effective Date 2024-06-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.05 g) Camphor (synthetic) (0.03 g)
Inactive Ingredients
Aloe Vera Leaf Arnica Montana Flower Castor Oil Cetyl Myristoleate Water Glycerin Glyceryl Laurate Glyceryl Ricinoleate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Lavender Oil Demeton-s-methylsulfone 1-palmitoyl-2-oleoyl-sn-glycero-3-(phospho-rac-(1-glycerol)) Shea Butter Willow Bark Disodium .alpha.-tocopheryl Phosphate, D- Turmeric

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-03

Description

Menthol 5% Camphor 3%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 5% Camphor 3%

Uses:

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

Warnings:

For external use only ▪Avoid contact with the eyes ▪ Do not apply to wounds or bandaged skin ▪ Do not bandage

Stop use and consult a doctor if: ▪ condition worsens ▪ symptoms persist for more than 7 days or clear up and reoccur ▪redness is present ▪irritation develops

Directions:

Adults and children 12 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age consult a doctor.

Active Ingredient

Menthol 5%

Camphor 3%

Other Information

Flammable: Keep away from excessive heat or open flame. Keep out of direct sunlight: Store at 50-86F (15-30C)

Rub the Pain Away

Rub On Relief Net Wt 3.0 OZ (88mL)

Inactive Ingredients:

Aloe Barbadensis Inner Leaf Juice, Aqua, Arnica Montana Flower Extract, Ricinus Communis (Castor) Seed Oil, Cetyl Myristoleate, Glycerin USP, Caprylyl Glycol, Glyceryl Laurate, Glyceryl Undecylenate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Methyl Sulfonyl Methane, Palmitoylethanolamide, Butyrospermum Parkii (Shea) Butter, D-Alpha Tocopheryl Acetate, Curcuma Longa (Turmeric) Root Extract, Salix Alba (Willow) Bark Extract.

When Using This Product

When using this product ▪ use only as directed ▪ do not apply heat (heating pads) or apply patches to area ▪ do not use with other topical analgesics - avoid contact with eyes, mucos membranes, and genital area - Do not expose application site to heat or direct sunlight

Keep Out of Reach of Children

Keep out of the reach of children.

If accidentally swallowed get medical help or contact a Poison Control Center immediately.

If Pregnant Or Breast Feeding:

If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately

Stop Usage Immediately and As A Doctor If:

The condition worsens or symptoms persist for more than 7 days or clear up and reoccur, redness or swelling is present, irritation develops


Structured Label Content

Uses:

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

Purpose

Topical Analgesic

Warnings: (WARNINGS:)

For external use only ▪Avoid contact with the eyes ▪ Do not apply to wounds or bandaged skin ▪ Do not bandage

Stop use and consult a doctor if: ▪ condition worsens ▪ symptoms persist for more than 7 days or clear up and reoccur ▪redness is present ▪irritation develops

Directions:

Adults and children 12 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age consult a doctor.

Active Ingredient

Menthol 5%

Camphor 3%

Other Information

Flammable: Keep away from excessive heat or open flame. Keep out of direct sunlight: Store at 50-86F (15-30C)

Rub the Pain Away (RUB THE PAIN AWAY)

Rub On Relief Net Wt 3.0 OZ (88mL)

Inactive Ingredients:

Aloe Barbadensis Inner Leaf Juice, Aqua, Arnica Montana Flower Extract, Ricinus Communis (Castor) Seed Oil, Cetyl Myristoleate, Glycerin USP, Caprylyl Glycol, Glyceryl Laurate, Glyceryl Undecylenate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Methyl Sulfonyl Methane, Palmitoylethanolamide, Butyrospermum Parkii (Shea) Butter, D-Alpha Tocopheryl Acetate, Curcuma Longa (Turmeric) Root Extract, Salix Alba (Willow) Bark Extract.

When Using This Product (WHEN USING THIS PRODUCT)

When using this product ▪ use only as directed ▪ do not apply heat (heating pads) or apply patches to area ▪ do not use with other topical analgesics - avoid contact with eyes, mucos membranes, and genital area - Do not expose application site to heat or direct sunlight

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of the reach of children.

If accidentally swallowed get medical help or contact a Poison Control Center immediately.

If Pregnant Or Breast Feeding: (If pregnant or breast-feeding:)

If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately

Stop Usage Immediately and As A Doctor If: (Stop Usage immediately and as a doctor if:)

The condition worsens or symptoms persist for more than 7 days or clear up and reoccur, redness or swelling is present, irritation develops


Advanced Ingredient Data


Raw Label Data

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