S-Oint DIAPER RASH OINTMENT AND SKIN PROTECTANT

S-Oint DIAPER RASH AND SKIN PROTECTANT by

Drug Labeling and Warnings

S-Oint DIAPER RASH AND SKIN PROTECTANT by is a Otc medication manufactured, distributed, or labeled by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

S-OINT DIAPER RASH AND SKIN PROTECTANT- zinc oxide ointment 
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

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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S-Oint DIAPER RASH OINTMENT AND SKIN PROTECTANT

Drug Facts

ACTIVE INGREDIENT

Zinc Oxide, 40%

PURPOSE

Skin protectant

USES

Helps treat and prevent diaper rash, Protects chafed skin due to diaper rash and helps seal out wetness

WARNINGS

For external use only

When using this product
 Avoid contact with the eyes

Stop use and ask a doctor if Condition worsens or does not improve after 7 days

Keep out of reach of children.
To prevent accidental ingestion. If swallowed, seek medical help or call Poison Control Center immediately.

DIRECTIONS

Change wet and soiled diaper immediately, cleanse the diaper area and allow to dry, apply ointment liberally as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime

OTHER INFORMATION

Storage temperature: not to exceed 30°C (86°F),

Remove foil seal from the tube's tip,

Use with infants, children and Adults,

Will stain clothing and fabric

INACTIVE INGREDIENTS

Castor Oil, Mineral Oil, Paraffin, Peruvian Balsam, White Petrolatum

Questions or comments?

1-800-572-6632 between 9am and 4 pm EST, Monday - Friday.

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

S-OINT DIAPER RASH AND SKIN PROTECTANT 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	400 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
BALSAM PERU (UNII: 8P5F881OCY)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-022-30	1 in 1 CARTON	04/01/2021	02/08/2023
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/01/2021	02/08/2023

Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)

Establishment
Name	Address	ID/FEI	Business Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED		860186917	manufacture(73921-022)

Revised: 2/2023

Document Id: f42b2912-247c-7619-e053-2a95a90ae1ba

34390-5

Set id: 155adc05-0420-476f-91a7-95241eb519c7

Version: 2

Effective Time: 20230208