SPL v1
SPL
SPL Set ID 17de1adc-7b25-24e4-e063-6294a90a39df
Route
TOPICAL
Published
Effective Date 2024-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5.5 g) Borneol (6.25 g) Cinnamomum Camphora Leaf (12.5 g) Barleria Lupulina Whole
Inactive Ingredients
Paraffin White Petrolatum

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-05-01

Description

Uses For the temporary relief of pain and itching associated with: asimple backache aarthritis nstrains abruises nsprains.


Medication Information

Warnings and Precautions

Warning For external use only When using this product a Use only as directed. a Avoid contact with eye and mucous membranes. a Do not apply to wounds, damaged or irritated skin. a Do not bandage tightly or use with heating pad.

Indications and Usage

Uses For the temporary relief of pain and itching associated with: asimple backache aarthritis nstrains abruises nsprains.

Directions a Apply generously of affected areas and massage gently until cream is absorbed in to the skin. a For adults and children over 12 apply on the affected area not more than 3-4 times daily. a For children under 12 years of age, consult a doctor before using.

Other Information a This product may cause allergic reaction on some individual. Test on small area before use.

Dosage and Administration

Uses For the temporary relief of pain and itching associated with: asimple backache aarthritis nstrains abruises nsprains.

Description

Uses For the temporary relief of pain and itching associated with: asimple backache aarthritis nstrains abruises nsprains.

Section 50565-1

Keep out of reach of children. a If swallowed, get medical attention or contact a Poison Center immediately

Section 51727-6

Inactive Ingredients White Petrolatum, Hard Paraffin

Section 51945-4

Drug Fact Drug Fact (continue)

Active Ingredients Purpose Barleria Lupulia oil 25% External Antipruritic Borneo! Camphor 12.5% External Analgesic Champor 25% External Analgesic Menthol 11% External Analgesic

Uses For the temporary relief of pain and itching associated with: asimple backache aarthritis nstrains abruises nsprains.

Warning For external use only When using this product a Use only as directed. a Avoid contact with eye and mucous membranes. a Do not apply to wounds, damaged or irritated skin. a Do not bandage tightly or use with heating pad.

Inactive Ingredients White Petrolatum, Hard Paraffin

Stop use and ask doctor if a Condition worsens. Servere skin irritation occurs. a Symptoms persist for more than 7 days.

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use. Keep out of reach of children. a If swallowed, get medical attention or contact a Poison Center immediately

Directions a Apply generously of affected areas and massage gently until cream is absorbed in to the skin. a For adults and children over 12 apply on the affected area not more than 3-4 times daily. a For children under 12 years of age, consult a doctor before using.

Other Information a This product may cause allergic reaction on some individual. Test on small area before use.

Question or comments? a 1-323-698-8790

Section 55105-1

Uses For the temporary relief of pain and itching associated with: asimple backache aarthritis nstrains abruises nsprains.

Section 55106-9

Active Ingredients Purpose Barleria Lupulia oil 25% External Antipruritic Borneo! Camphor 12.5% External Analgesic Champor 25% External Analgesic Menthol 11% External Analgesic


Structured Label Content

Indications and Usage (34067-9)

Uses For the temporary relief of pain and itching associated with: asimple backache aarthritis nstrains abruises nsprains.

Directions a Apply generously of affected areas and massage gently until cream is absorbed in to the skin. a For adults and children over 12 apply on the affected area not more than 3-4 times daily. a For children under 12 years of age, consult a doctor before using.

Other Information a This product may cause allergic reaction on some individual. Test on small area before use.

Dosage and Administration (34068-7)

Uses For the temporary relief of pain and itching associated with: asimple backache aarthritis nstrains abruises nsprains.

Warnings and Precautions (34071-1)

Warning For external use only When using this product a Use only as directed. a Avoid contact with eye and mucous membranes. a Do not apply to wounds, damaged or irritated skin. a Do not bandage tightly or use with heating pad.

Section 50565-1 (50565-1)

Keep out of reach of children. a If swallowed, get medical attention or contact a Poison Center immediately

Section 51727-6 (51727-6)

Inactive Ingredients White Petrolatum, Hard Paraffin

Section 51945-4 (51945-4)

Drug Fact Drug Fact (continue)

Active Ingredients Purpose Barleria Lupulia oil 25% External Antipruritic Borneo! Camphor 12.5% External Analgesic Champor 25% External Analgesic Menthol 11% External Analgesic

Uses For the temporary relief of pain and itching associated with: asimple backache aarthritis nstrains abruises nsprains.

Warning For external use only When using this product a Use only as directed. a Avoid contact with eye and mucous membranes. a Do not apply to wounds, damaged or irritated skin. a Do not bandage tightly or use with heating pad.

Inactive Ingredients White Petrolatum, Hard Paraffin

Stop use and ask doctor if a Condition worsens. Servere skin irritation occurs. a Symptoms persist for more than 7 days.

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use. Keep out of reach of children. a If swallowed, get medical attention or contact a Poison Center immediately

Directions a Apply generously of affected areas and massage gently until cream is absorbed in to the skin. a For adults and children over 12 apply on the affected area not more than 3-4 times daily. a For children under 12 years of age, consult a doctor before using.

Other Information a This product may cause allergic reaction on some individual. Test on small area before use.

Question or comments? a 1-323-698-8790

Section 55105-1 (55105-1)

Uses For the temporary relief of pain and itching associated with: asimple backache aarthritis nstrains abruises nsprains.

Section 55106-9 (55106-9)

Active Ingredients Purpose Barleria Lupulia oil 25% External Antipruritic Borneo! Camphor 12.5% External Analgesic Champor 25% External Analgesic Menthol 11% External Analgesic


Advanced Ingredient Data


Raw Label Data

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