Sinopharm Group Dezhong (Foshan) Pharmaceutical Co., Ltd

Bai Healing Cold Patch by

Drug Labeling and Warnings

Bai Healing Cold Patch by is a Otc medication manufactured, distributed, or labeled by Sinopharm Group Dezhong (Foshan) Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BAI HEALING COLD 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%

Purpose

Menthol           Topical Analgesic

Uses

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?

535 W Allen Ave, Unit 17, San Dimas, CA 91773
Tel: 323-859-1307

Manufactured by

Sinopharm Group Dezhong (Foshan) Pharmaceutical Co., Ltd
No. 89 Foping Road, Chanchang District, Foshan, Guangdong, China

Made in China

U.S. Distributor

Bai Healing LLC
535 W Allen Ave, Unit 17, San Dimas, CA 91773

Inactive Ingredients

NOTOPTERYGIUM INCISUM ROOT, ANGELICA BISERRATA ROOT, ANGELICA DAHURICA ROOT, DRAGON'S BLOOD, CORYDALIS YANHUSUO TUBER, TETRAPANAX PAPYRIFER STEM, SAFFLOWER, EVODIAMINE, NATURAL LATEX RUBBER

Drug Facts

BAI HEALING COLD PATCH 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82435-900
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.62 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
NOTOPTERYGIUM INCISUM ROOT (UNII: 5Z2WW4J6RI)
ANGELICA BISERRATA ROOT (UNII: OJ90180B22)
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
DRAGON'S BLOOD (UNII: M3YJ2C28IC)
CORYDALIS YANHUSUO TUBER (UNII: 0TUP42692Z)
TETRAPANAX PAPYRIFER STEM (UNII: 3E6X0C23AB)
SAFFLOWER (UNII: 4VBL71TY4Y)
EVODIAMINE (UNII: C01825BVNL)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82435-900-03	3 in 1 BOX	06/28/2019
1		4 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/28/2019	10/27/2022

Labeler - Sinopharm Group Dezhong (Foshan) Pharmaceutical Co., Ltd (529754442)

Registrant - Sinopharm Group Dezhong (Foshan) Pharmaceutical Co., Ltd (529754442)

Establishment
Name	Address	ID/FEI	Business Operations
Sinopharm Group Dezhong (Foshan) Pharmaceutical Co., Ltd		529754442	manufacture(82435-900)

Revised: 10/2022

Document Id: 4dfb400d-9455-413d-b383-24df99fa198d

34390-5

Set id: 1c22075a-14dc-4dd5-aee0-ce3409477955

Version: 32812

Effective Time: 20221027

 

Sinopharm Group