FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT PEPPERMINT TWIST- colloidal oatmeal cream

First Aid Beauty FAB Ultra Repair Skin Protectant Peppermint Twist by

Drug Labeling and Warnings

First Aid Beauty FAB Ultra Repair Skin Protectant Peppermint Twist by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Colloidal Oatmeal 0.5%

Purpose

Skin Protectant

Uses

• Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites

Warnings

For external use only.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not get into 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 as needed

INACTIVE INGREDIENT

Water, stearic acid, glycerin, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, glyceryl stearate SE, cetearyl alcohol, butyrospermum parkii (shea) butter, dimethicone, squalane, phenoxyethanol, caprylyl glycol, xanthan gum, allantoin, sodium
hydroxide, mentha arvensis (cornmint) oil, tetrasodium EDTA, mentha spicata (spearmint) leaf oil, chrysanthemum parthenium (feverfew) extract, eucalyptus globulus leaf oil, mentha piperita (peppermint) oil, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, mentha citrata bergamot mint, ceramide NP

Questions:

888-FAB-3063

SPL UNCLASSIFIED SECTION

MADE IN USA

FIRST AID BEAUTY LTD

NEWTON, MA 02458

WWW.FIRSTAIDBEAUTY.COM

PRINCIPAL DISPLAY PANEL - 396.8 g (14 oz)

First Aid Beauty

FAB

Ultra Repair® Cream

Intense Hydration

Pepermint Twist

Skin Protectant Colloidal Oatmeal

Net Wt. 396.8 g (14 oz)

INGREDIENTS AND APPEARANCE

FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT PEPPERMINT TWIST 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SPEARMINT OIL (UNII: C3M81465G5)
MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)
PEPPERMINT OIL (UNII: AV092KU4JH)
TETRASODIUM EDTA (UNII: MP1J8420LU)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
SQUALANE (UNII: GW89575KF9)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
LICORICE (UNII: 61ZBX54883)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
CERAMIDE NP (UNII: 4370DF050B)
TANACETUM PARTHENIUM WHOLE (UNII: 6GE7Z0761K)
MENTHA AQUATICA VAR. CITRATA LEAF (UNII: ZMA317E4J7)
EUCALYPTUS GLOBULUS LEAF OIL (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-046-39	396.8 g in 1 JAR; Type 0: Not a Combination Product	10/01/2024
2	NDC: 84126-046-01	2 in 1 PACKAGE	10/01/2024
2		396.8 g in 1 JAR; Type 0: Not a Combination Product
3	NDC: 84126-046-56	56.7 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/01/2024

Labeler - The Procter & Gamble Manufacturing Company (004238200)