GOHEAL- white petrolatum ointment
Adapted Living Solutions Inc.

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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GoHeal Ointment

Active Ingredient

White Petrolatum USP (50%)

Purpose

Skin protectant

Uses

For the temporary protection of minor cuts, scrapes, burns and sunburn.
Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.

Warnings

For External Use Only

Do not use

over deep or puncture wounds infections or lacerations. Ask a doctor

When using this product

avoid contact with eyes

Stop use and ask a doctor

if condition worsens or does not improve within 7 days

Keep out of reach of children

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

Directions

Apply product liberally as often as necessary

Inactive ingredient

Punica Granatum Seed Oil
Cocos Nucifera (Coconut) Oil
Sesamum Indicum (Sesame) Seed Oil
Neem (Azadirachta indica) leaf extract
Citrus Reticulata (Tangerine) Peel Essential Oil
Olea Europaea (Olive) Fruit Oil
Aloe Vera Leaf Extract
Moringa oleifera seed oil,

Water

Package Label

Label

GOHEAL
white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81928-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	15 g in 30 g

Ingredient Name	Strength
Inactive Ingredients
PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)
SESAME OIL (UNII: QX10HYY4QV)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
WATER (UNII: 059QF0KO0R)
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81928-002-01	30 g in 1 TUBE; Type 0: Not a Combination Product	07/13/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/13/2022

Labeler - Adapted Living Solutions Inc. (204297027)

Name	Address	ID/FEI	Business Operations
Establishment
PRAKRUTI PRODUCTS PRIVATE LIMITED		876984502	manufacture(81928-002)