RPS CARE- allantoin, camphor cream

RPS CARE by

Drug Labeling and Warnings

RPS CARE by is a Otc medication manufactured, distributed, or labeled by Lavior Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Camphor 0.2%

Allantoin 0.5%

PURPOSE

External Analgesic

Skin Protectant

Uses

Helps provide relief of symptoms of cold sores and dry lips

WARNINGS

For external use only

WHEN USING

When using this product

Keep out of eyes. Rinse with water to remove.

STOP USE

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

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.

Directions

Directions

• apply to lips not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor

INACTIVE INGREDIENT

Aqua, Glycerin, Inula Viscosa Flower/Leaf/Stem Extract, Xanthan Gum, Glyceryl Stearate Citrate, Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Propanediol-1,3, Sodium Benzoate, Potassium Sorbate, Maltodextrin, Biosaccharide Gum-1, Bisabolol, Tocopheryl Acetate (Vitamin E), Sodium Gluconate, Citric Acid.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RPS CARE 
allantoin, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71521-438
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	0.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPANEDIOL (UNII: 5965N8W85T)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM GLUCONATE (UNII: R6Q3791S76)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
DITTRICHIA VISCOSA WHOLE (UNII: 3SYW69FH88)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CETYL ALCOHOL (UNII: 936JST6JCN)
LEVOMENOL (UNII: 24WE03BX2T)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71521-438-30	1 in 1 BOX	02/27/2018	12/01/2018
1		30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/27/2018

Labeler - Lavior Inc. (080685327)

Establishment
Name	Address	ID/FEI	Business Operations
Lavior Inc.		080685327	manufacture(71521-438)