Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID ffadc904-8e9d-4cb8-815a-d583bbdb3f0b
Route
TOPICAL
Published
Effective Date 2012-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g)
Inactive Ingredients
Angelica Sinensis Root Pistacia Lentiscus Resin Myrrh Quince Safflower Sanguisorba Officinalis Top Sesame Oil Yellow Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-10-25 Until 2028-10-26

Description

Active ingredient Menthol 1%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

For the temporary relief of pain and itching associated with:

  • minor burns
  • sunburn
Dosage and Administration

Directions

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

children under 2 years of age: do not use, consult a doctor

Description

Active ingredient Menthol 1%

Section 44425-7

Other information

keep container tightly closed

store at 15 to 30 C (59 to 86 F)

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product

avoid contact with the eyes

Section 50569-3



Stop use and ask a doctor if

condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

Section 51727-6

Inactive ingredients

Dong-quai [Angelica sinensis (Oliv.) Diels] root, mastic (Pistacia Lentiscus L.) resin, myrrh oleo-gum resin, quince (Chaenomeles spp.) fruit, safflower flower,sanguisorba (Sanguisorba officinalis L.) root, sesame oil,and yellow wax.



Section 51945-4

CHING WAN HUNG, Soothing Herbal Balm, External Analgesic, 0.35 oz (10 g), NDC 33217-001-01

Section 53413-1

Questions or comments? Call (888) 221-3496  M-F 9am to 5pm

Section 55105-1

Purpose

External analgesic

Section 55106-9

Active ingredient

Menthol 1%


Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of pain and itching associated with:

  • minor burns
  • sunburn
Dosage and Administration (34068-7)

Directions

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

children under 2 years of age: do not use, consult a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

keep container tightly closed

store at 15 to 30 C (59 to 86 F)

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product

avoid contact with the eyes

Section 50569-3 (50569-3)



Stop use and ask a doctor if

condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

Section 51727-6 (51727-6)

Inactive ingredients

Dong-quai [Angelica sinensis (Oliv.) Diels] root, mastic (Pistacia Lentiscus L.) resin, myrrh oleo-gum resin, quince (Chaenomeles spp.) fruit, safflower flower,sanguisorba (Sanguisorba officinalis L.) root, sesame oil,and yellow wax.



Section 51945-4 (51945-4)

CHING WAN HUNG, Soothing Herbal Balm, External Analgesic, 0.35 oz (10 g), NDC 33217-001-01

Section 53413-1 (53413-1)

Questions or comments? Call (888) 221-3496  M-F 9am to 5pm

Section 55105-1 (55105-1)

Purpose

External analgesic

Section 55106-9 (55106-9)

Active ingredient

Menthol 1%


Advanced Ingredient Data


Raw Label Data

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