Petroleum Jelly by Adapted Living Solutions Inc. / Colaco & Valerie Private Limited Go Heal Ointment

Petroleum Jelly by

Drug Labeling and Warnings

Petroleum Jelly by is a Otc medication manufactured, distributed, or labeled by Adapted Living Solutions Inc., Colaco & Valerie Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PETROLEUM JELLY- 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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Go Heal 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

PETROLEUM JELLY 
white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81928-000
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81928-000-01	30 g in 1 TUBE; Type 0: Not a Combination Product	03/28/2022	05/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/28/2022	05/02/2022

Labeler - Adapted Living Solutions Inc. (204297027)

Establishment
Name	Address	ID/FEI	Business Operations
Colaco & Valerie Private Limited		876810835	manufacture(81928-000)

Revised: 5/2022

Document Id: de0b8bb3-a540-4126-e053-2a95a90aa687

34390-5

Set id: db48d5aa-9264-9cb2-e053-2995a90a0882

Version: 2

Effective Time: 20220502