HEALING FOOT AND LEG BALM- skin protectant ointment

Healing Foot and Leg Balm by

Drug Labeling and Warnings

Healing Foot and Leg Balm by is a Otc medication manufactured, distributed, or labeled by Skinfix, Inc., Canadian Custom Packaging Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Colloidal Oatmeal 2%

Purpose

Skin Protectant

Keep out of reach of children

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

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to . eczema . rash . dermatitis

Warnings

For external use only

When using this product Avoid contact with eyes

Stop use and ask a doctor if . condition worsens . symptoms last more than 7 days or clear up and occur again within a few days

Directions

Apply balm liberally as needed, especially after bathing

Inactive Ingredients

aloe barbadensis leaf juice, beeswax, butyrospermum parkii (shea) butter, cocos nucifera (coconut) oil, helianthus annuus (sunflower) oil, liquidambar orientalis oil and extract (styrax), myroxylon balsamum resin (balsam tolu), paraffin, petrolatum, simmondsia chinensis (jojoba) seed oil, styrax benzoin resin extract (benzoin), tocopherol, zinc oxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEALING FOOT AND LEG BALM 
skin protectant ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
ZINC OXIDE (UNII: SOI2LOH54Z)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
WHITE WAX (UNII: 7G1J5DA97F)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PARAFFIN (UNII: I9O0E3H2ZE)
SHEA BUTTER (UNII: K49155WL9Y)
COCONUT OIL (UNII: Q9L0O73W7L)
BENZOIN RESIN (UNII: GK21SBA74R)
LIQUIDAMBAR ORIENTALIS RESIN (UNII: 63V91G4W93)
TOLU BALSAM (UNII: TD2LE91MBE)
aloe (UNII: V5VD430YW9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61328-007-01	60 g in 1 TUBE; Type 0: Not a Combination Product	09/23/2016
2	NDC: 61328-007-02	120 g in 1 TUBE; Type 0: Not a Combination Product	09/23/2016
3	NDC: 61328-007-97	7 g in 1 POUCH; Type 0: Not a Combination Product	09/23/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/19/2013

Labeler - Skinfix, Inc. (203158183)

Registrant - Skinfix, Inc. (203158183)

Establishment
Name	Address	ID/FEI	Business Operations
Canadian Custom Packaging Company		207062514	manufacture(61328-007)