ADVACED FIRST AID A AND D- white petrolatum ointment

Advaced First Aid A and D by

Drug Labeling and Warnings

Advaced First Aid A and D by is a Otc medication manufactured, distributed, or labeled by ADVANCED FIRST AID, INC., ULTRA SEAL CORPORATION, ULTRA TAB LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (In Each Gram): White Petrolatum 93.5%

PURPOSE

Skin protectant

INDICATIONS & USAGE

Uses:

Temporarily protects minor: cuts scrapes burns

temporarily protects and helps chapped or cracked skin and lips

helps protect lips from drying effects of wind and cold weather

WARNINGS

Warnings:

for external use only

When using this product:

avoid contact with eyes

STOP USE

Stop use and ask a doctor if:

condition worsens

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

DO NOT USE

Do not use on:

deep or puncture wounds

animal bites

serious burns

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

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

DOSAGE & ADMINISTRATION

Directions:

apply as needed

OTHER SAFETY INFORMATION

Other Information:

Tamper Evident. Do not use if packet is torn, cut or opened.

Avoid excessive heat and humidity.

Store at a controlled room temperature 15° to 30°C (59° to 86°F).

INACTIVE INGREDIENT

Inactive Ingredients:

Corn oil, light mineral oil, Vitamin A palmitate and Vitamin D

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADVACED FIRST AID A AND D 
white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67060-375
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	937.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
VITAMIN A (UNII: 81G40H8B0T)
ERGOCALCIFEROL (UNII: VS041H42XC)
CORN OIL (UNII: 8470G57WFM)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67060-375-68	100 in 1 CARTON	04/07/2015	10/17/2016
1		2 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 67060-375-67	250 in 1 CARTON	04/07/2015	10/17/2016
2	NDC: 67060-375-02	2 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 67060-375-53	369 g in 1 JAR; Type 0: Not a Combination Product	10/17/2016
4	NDC: 67060-375-31	113 g in 1 TUBE; Type 0: Not a Combination Product	10/17/2016
5	NDC: 67060-375-47	144 in 1 CARTON	10/17/2016
5	NDC: 67060-375-05	5 g in 1 PACKET; 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	04/07/2015

Labeler - ADVANCED FIRST AID, INC. (114477180)

Registrant - ADVANCED FIRST AID, INC. (114477180)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	pack(67060-375)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA TAB LABORATORIES, INC.		151051757	manufacture(67060-375)