SPL v2
SPL
SPL Set ID e69d7f9e-881e-4502-a239-03308387bbac
Route
TOPICAL
Published
Effective Date 2023-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g) Camphor (natural)
Inactive Ingredients
Water Alcohol Glycerin .alpha.-tocopherol Acetate Sheanut Arnica Montana Flower Hamamelis Virginiana Top Ammonium Acryloyldimethyltaurate/vp Copolymer Candelilla Wax Octenylsuccinic Acid Biosaccharide Gum-1 Phenoxyethanol Hydrated Silica Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-15

Description

Active Ingredients                                                      Purpose Camphor (5%)                                                  Topical Analgesic Menthol (5%)                                                     Topical Analgesic


Medication Information

Description

Active Ingredients                                                      Purpose Camphor (5%)                                                  Topical Analgesic Menthol (5%)                                                     Topical Analgesic

Uses

Temporary relief of minor aches and pains in muscles and joints associated with: • simple backache • strains • sprains

• arthritis • bruises

Section 51727-6

Water, Alcohol, Glycerin, Tocopheryl Acetate, ButyrospermumParkii (Shae Butter) Extract, Arnica Montana Flower Extract, Hamamelis Virginiana (Witch Hazel) Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Euphorbia Cerifera (Candelilla) Wax, Sodium Starch Octenylsuccinate,

Bio-Saccharide Gum-1, Phenoxyethanol, Hydrated Silica, Ethylhexylglycerin

Section 55105-1

Section 55106-9

Active Ingredients                                                     Purpose

Camphor (5%)                                                  Topical Analgesic



Menthol (5%)                                                     Topical Analgesic

Warnings

• For external use only

• Do not apply to wounds or damaged skin

• Do not bandage tightly • Avoid contact with eyes

• Keep out of reach of children

• If swallowed, get medical help or contact a Poison Control Center immediately

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product     and consult a physician

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

Directions

• For best results, shake well and apply generously

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

• For children under 2 years of age: Consult a doctor

Product Label


Structured Label Content

Uses

Temporary relief of minor aches and pains in muscles and joints associated with: • simple backache • strains • sprains

• arthritis • bruises

Section 51727-6 (51727-6)

Water, Alcohol, Glycerin, Tocopheryl Acetate, ButyrospermumParkii (Shae Butter) Extract, Arnica Montana Flower Extract, Hamamelis Virginiana (Witch Hazel) Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Euphorbia Cerifera (Candelilla) Wax, Sodium Starch Octenylsuccinate,

Bio-Saccharide Gum-1, Phenoxyethanol, Hydrated Silica, Ethylhexylglycerin

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)

Active Ingredients                                                     Purpose

Camphor (5%)                                                  Topical Analgesic



Menthol (5%)                                                     Topical Analgesic

Warnings

• For external use only

• Do not apply to wounds or damaged skin

• Do not bandage tightly • Avoid contact with eyes

• Keep out of reach of children

• If swallowed, get medical help or contact a Poison Control Center immediately

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product     and consult a physician

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

Directions

• For best results, shake well and apply generously

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

• For children under 2 years of age: Consult a doctor

Product Label (Product label)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)