BAI HEALING HEAT PATCH- menthol patch

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Menthol 4.62%
Available from:
Sinopharm Group Dezhong (Foshan) Pharmaceutical Co., Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Menthol           Topical Analgesic For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains and bruises. pregnant. lactating women. condition worsens. redness is present. irritation develops. symptoms persist for more than 7 days or clear up and occur again within a few days.
Authorization status:
OTC monograph not final
Authorization number:
72479-317-03

BAI HEALING HEAT PATCH- menthol patch

Sinopharm Group Dezhong (Foshan) Pharmaceutical Co., Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sinopharm Group Dezhong (Foshan) Pharmaceutical Co., Ltd

Active Ingredients

Menthol 4.62%

Purpos e

Menthol Topical Analgesic

Us es

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple

backache, strains, sprains and bruises.

Warnings

FOR EXTERNAL USE ONLY. This product contains latex.

Ask a Doctor or Pharmacist Before Use If You Are

pregnant.

lactating women.

When Using This Product

Do not apply to wounds or damaged, broken or irritated skin.

Stop Use and Ask a Doctor If

condition worsens.

redness is present.

irritation develops.

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

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

KEEP OUT OF REACH OF CHILDREN.

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

Directions

Adults (12 years and older)

- Clean and dry the affected area.

- Peel film off from patch and apply the herbal formula side onto skin.

- Lasts for up to 24 hours; repeat as necessary and no less than 2 hours between applications.

- For the best result, a 2-week course of treatment is recommended.

- Children under 12 years: Consult your physician.

Other Information

Keep pouch sealed and avoid storage in direct sunlight.

Questions or Comments?

1118 Cleghorn Dr. #E Diamond Bar, CA 91765

Tel: 323-859-1307

Manufactured by

Sinopharm Group Dezhong (Foshan) Pharmaceutical Co., Ltd

No. 89 Foping Road, Changcheng District, Foshan, Guangdong 528000 China

Made in China

U.S. Distributor

Bai Healing LLC

Add: 1118 Cleghorn Dr. #E, Diamond Bar, CA 91765

Inactive Ingredients

GINGER, TETRAPANAX PAPYRIFER STEM, ANGELICA BISERRATA ROOT, CLEMATIS

CHINENSIS ROOT, LIQUIDAMBAR ORIENTALIS FRUIT, ARISAEMA ERUBESCENS WHOLE,

CINNAMOMUM CASSIA TWIG, PAEONIA VEITCHII ROOT, NOTOPTERYGIUM INCISUM

ROOT, ANGELICA PUBESCENS ROOT, NATURAL LATEX RUBBER

Drug Facts

BAI HEALING HEAT PATCH

menthol patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:72479 -317

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

4.6 2 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

GINGER (UNII: C5529 G5JPQ)

TETRAPANAX PAPYRIFER STEM (UNII: 3E6 X0 C23AB)

ANGELICA BISERRATA RO O T (UNII: OJ9 0 18 0 B22)

CLEMATIS CHINENSIS RO O T (UNII: 8 Z18 N528 CU)

LIQ UIDAMBAR O RIENTALIS FRUIT (UNII: OTA52GQDFW)

Sinopharm Group Dezhong (Foshan) Pharmaceutical Co., Ltd

ARISAEMA ERUBESCENS WHO LE (UNII: SF6 XYE1WTC)

CINNAMO MUM CASSIA TWIG (UNII: 4UD6 VQR2UP)

PAEO NIA VEITCHII RO O T (UNII: VX6 GD6 M9 3V)

NO TO PTERYGIUM INCISUM RO O T (UNII: 5Z2WW4J6 RI)

ANGELICA PUBESCENS RO O T (UNII: 0 MF1EI0 1KJ)

NATURAL LATEX RUBBER (UNII: 2LQ0 UUW8 IN)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:72479 -317-0 3

3 in 1 BOX

0 6 /28 /20 19

1

4 g in 1 PATCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 6 /28 /20 19

Labeler -

Sinopharm Group Dezhong (Foshan) Pharmaceutical Co., Ltd (530841720)

Registrant -

Sinopharm Group Dezhong (Foshan) Pharmaceutical Co., Ltd (530841720)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Sino pharm Gro up Dezho ng (Fo shan) Pharmaceutical Co ., Ltd

530 8 41720

ma nufa c ture (72479 -317)

Revised: 9/2019

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