amrutanjan relief pain balm

amrutanjan relief pain balm
SPL v14
SPL
SPL Set ID ddee6714-8b18-4d87-944b-8467fda22e6b
Route
topical
Published
Effective Date 2025-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (synthetic) (0.1 g) menthol (0.08 g) salicylic acid (0.14 g)
Inactive Ingredients
butylated hydroxytoluene cinnamon leaf oil citronella oil clove oil d&c yellow no. 11 east indian lemongrass oil eucalyptus oil light mineral oil microcrystalline wax paraffin white petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-07-22

Purpose

Pain reliever

Description

Camphor 10% w/w Menthol 8% w/w Methyl salicylate 14% w/w


Medication Information

Warnings

For external use only

Do not use

• on wounds or damaged skin, mucous membranes, broken or irritated skin

• near an open flame

• otherwise than as directed

When using this product

• avoid contact with the eyes

• do not bandage tightly or use with heating pad

• do not microwave

• do not heat

• do not add to hot water or any container where water is heating. May cause splattering and result in burns.

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days or is accompanied by fever, rash, or persistent headaches

• redness or irritation develops

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

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains

Purpose

Pain reliever

Directions

• adults and children over 12 years: Apply gently to the affected area 2-3 times daily, or as directed by a doctor. Do not use more than 3 times daily.

• children under 12 years of age: do not use, consult a doctor

• this product may cause an allergic reaction in a few individuals. Test on a small area before use

• see important warning "When using this product"

Other Information

• store at room temperature

• tamper evident: do not purchase if carton seal is broken or tampered

Inactive Ingredients

butylated hydroxytoluene, cinnamon leaf oil, citronella oil, clove oil, D&C yellow no. 11, east indian lemongrass oil, eucalyptus oil, light mineral oil, microcrystalline wax, paraffin, white petrolatum

Description

Camphor 10% w/w Menthol 8% w/w Methyl salicylate 14% w/w

Questions?

+1-866-799-6929

You may also report serious side effects to this phone number.

Mon-Fri 8:00 A.M. - 6:00 P.M.

Section 42229-5

PAIN SPECIALIST FOR OVER 130 YEARS

Since 1983 

Pure Healthy Essence

Manufactured by: Amrutanjan Health Care Ltd.,

Plot No.: 38 & 39, SIDCO Pharmaceutical Complex,

Alathur, Thiruporur, Chengalpattu,

Tamil Nadu, India 603110

MADE IN INDIA

Mfg. Lic. No. TN/25/00037

With over 130 years of proven expertise, Amrutanjan has been a trusted household name, relied by millions. Amrutanjan Relief Pain Balm is infused with Camphor along with Menthol and Methyl Salicylate, known for its temporary pain-relieving properties that helps to relieve minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains & sprains and bruises. Experience cooling and warming pain relief, crafted just for you.

TAMPER EVIDENT: Do not purchase if carton seal is broken or tampered.

RETAIN CARTON FOR COMPLETE DRUG FACTS

PENETRATING PAIN RELIEF

Website:

www.amrutanjanusa.com

Other Products:

Relief Strong Pain Balm

30g & 50g

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Packaging

Active Ingredients

Camphor 10% w/w

Menthol 8% w/w

Methyl salicylate 14% w/w


Structured Label Content

Warnings

For external use only

Do not use

• on wounds or damaged skin, mucous membranes, broken or irritated skin

• near an open flame

• otherwise than as directed

When using this product

• avoid contact with the eyes

• do not bandage tightly or use with heating pad

• do not microwave

• do not heat

• do not add to hot water or any container where water is heating. May cause splattering and result in burns.

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days or is accompanied by fever, rash, or persistent headaches

• redness or irritation develops

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

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains

Purpose

Pain reliever

Directions

• adults and children over 12 years: Apply gently to the affected area 2-3 times daily, or as directed by a doctor. Do not use more than 3 times daily.

• children under 12 years of age: do not use, consult a doctor

• this product may cause an allergic reaction in a few individuals. Test on a small area before use

• see important warning "When using this product"

Other Information (Other information)

• store at room temperature

• tamper evident: do not purchase if carton seal is broken or tampered

Inactive Ingredients (Inactive ingredients)

butylated hydroxytoluene, cinnamon leaf oil, citronella oil, clove oil, D&C yellow no. 11, east indian lemongrass oil, eucalyptus oil, light mineral oil, microcrystalline wax, paraffin, white petrolatum

Questions?

+1-866-799-6929

You may also report serious side effects to this phone number.

Mon-Fri 8:00 A.M. - 6:00 P.M.

Section 42229-5 (42229-5)

PAIN SPECIALIST FOR OVER 130 YEARS

Since 1983 

Pure Healthy Essence

Manufactured by: Amrutanjan Health Care Ltd.,

Plot No.: 38 & 39, SIDCO Pharmaceutical Complex,

Alathur, Thiruporur, Chengalpattu,

Tamil Nadu, India 603110

MADE IN INDIA

Mfg. Lic. No. TN/25/00037

With over 130 years of proven expertise, Amrutanjan has been a trusted household name, relied by millions. Amrutanjan Relief Pain Balm is infused with Camphor along with Menthol and Methyl Salicylate, known for its temporary pain-relieving properties that helps to relieve minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains & sprains and bruises. Experience cooling and warming pain relief, crafted just for you.

TAMPER EVIDENT: Do not purchase if carton seal is broken or tampered.

RETAIN CARTON FOR COMPLETE DRUG FACTS

PENETRATING PAIN RELIEF

Website:

www.amrutanjanusa.com

Other Products:

Relief Strong Pain Balm

30g & 50g

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Packaging

Active Ingredients (Active ingredients)

Camphor 10% w/w

Menthol 8% w/w

Methyl salicylate 14% w/w


Advanced Ingredient Data


Raw Label Data

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