private label camphor spirit usp

private label camphor spirit usp
SPL v2
SPL
SPL Set ID e42fbe63-b01c-4f85-e053-2a95a90a5143
Route
topical
Published
Effective Date 2017-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (natural) (100 mg)
Inactive Ingredients
alcohol water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2008-01-01

Purpose

Counterirritant

Description

Drug Facts


Medication Information

Warnings

For external use only.

Do not drink. If swallowed, immediately give 3 or 4 glases of water. Do not induce vomiting. If vomiting occurs, give fluids again. Do not give anything by mouth to an unconscious or convulsing person. Get medical attention immediately.

Avoid contact with eyes or mucous membranes.

Do not apply to irritated skin.

Purpose

Counterirritant

Directions

(dilute 3 parts olive oil and mix well)

Adults and children 2 yrs. and older. apply to th affected area not more than 3 or 4 times daily.

Children under 2 yrs of age: consult a doctor befre use.

Other Information

Flammable: Keep away from spark, heat and flame.

Inactive Ingredients

Alcohol 84%, Purified Water

Description

Drug Facts

Use

For the temporary relief of minor aches, muscle and joint pain associated with arthritis, strains, brusies and simple backache.

Section 42229-5



Drug Facts

Ddm Label

Leader Label

Sunmark Label

Active Ingredient

Camphor 10%

Quality Choice Label

When Using This Product

Do not bandage tightly.

Keep Out of Reach of Children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away. In case of eye contact, flush eyes with running water for 15 minutes, get medical attention.

Discontinue Use and Consult A Doctor If

condition worsens, or if excesive irritation develops.

symptoms persit for more than 7 days, or clear up and occur again within a few days.


Structured Label Content

Warnings

For external use only.

Do not drink. If swallowed, immediately give 3 or 4 glases of water. Do not induce vomiting. If vomiting occurs, give fluids again. Do not give anything by mouth to an unconscious or convulsing person. Get medical attention immediately.

Avoid contact with eyes or mucous membranes.

Do not apply to irritated skin.

Purpose

Counterirritant

Directions

(dilute 3 parts olive oil and mix well)

Adults and children 2 yrs. and older. apply to th affected area not more than 3 or 4 times daily.

Children under 2 yrs of age: consult a doctor befre use.

Other Information

Flammable: Keep away from spark, heat and flame.

Inactive Ingredients (Inactive ingredients)

Alcohol 84%, Purified Water

Use

For the temporary relief of minor aches, muscle and joint pain associated with arthritis, strains, brusies and simple backache.

Section 42229-5 (42229-5)



Drug Facts

Ddm Label (DDM Label)

Leader Label

Sunmark Label

Active Ingredient

Camphor 10%

Quality Choice Label

When Using This Product (When using this product)

Do not bandage tightly.

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

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away. In case of eye contact, flush eyes with running water for 15 minutes, get medical attention.

Discontinue Use and Consult A Doctor If (Discontinue use and consult a doctor if)

condition worsens, or if excesive irritation develops.

symptoms persit for more than 7 days, or clear up and occur again within a few days.


Advanced Ingredient Data


Raw Label Data

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